Food, drugs, devices › Central Admixture Pharmacy Services, Inc.
Drug recall: Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh
Central Admixture Pharmacy Services, Inc. (Allentown, PA) initiated this drug recall on 28 Apr 2023; FDA lists 108 product records under event 92253, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 22 Jun 2025. Initiation: voluntary: firm initiated. Central Admixture Pharmacy Services, Inc. has 10 enforcement events on this register, with a median of 32 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Central Admixture Pharmacy Services, Inc., Allentown, PA.
Reason for recall
"Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0648-2023 | Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1. | 307 bags | Class II | Terminated | 31 May 2023 |
| D-0649-2023 | Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1. | 215 bags | Class II | Terminated | 31 May 2023 |
| D-0650-2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1. | 255 bags | Class II | Terminated | 31 May 2023 |
| D-0651-2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1. | 151 bags | Class II | Terminated | 31 May 2023 |
| D-0652-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1. | 140 bags | Class II | Terminated | 31 May 2023 |
| D-0653-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1. | 338 bags | Class II | Terminated | 31 May 2023 |
| D-0654-2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1. | 254 bags | Class II | Terminated | 31 May 2023 |
| D-0655-2023 | Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1. | 12 bags | Class II | Terminated | 31 May 2023 |
| D-0656-2023 | Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2. | 144 bags | Class II | Terminated | 31 May 2023 |
| D-0657-2023 | Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2. | 24 bags | Class II | Terminated | 31 May 2023 |
| D-0658-2023 | Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1. | 267 bags | Class II | Terminated | 31 May 2023 |
| D-0659-2023 | Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1. | 350 bags | Class II | Terminated | 31 May 2023 |
| D-0660-2023 | Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1. | 544 bags | Class II | Terminated | 31 May 2023 |
| D-0661-2023 | Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1. | 269 bags | Class II | Terminated | 31 May 2023 |
| D-0662-2023 | Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1. | 476 bags | Class II | Terminated | 31 May 2023 |
| D-0663-2023 | Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1. | 308 bags | Class II | Terminated | 31 May 2023 |
| D-0664-2023 | Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1. | 84 bags | Class II | Terminated | 31 May 2023 |
| D-0665-2023 | Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1. | 48 bags | Class II | Terminated | 31 May 2023 |
| D-0666-2023 | Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1. | 613 bags | Class II | Terminated | 31 May 2023 |
| D-0667-2023 | Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1. | 476 bags | Class II | Terminated | 31 May 2023 |
| D-0668-2023 | Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1. | 12,888 bags | Class II | Terminated | 31 May 2023 |
| D-0669-2023 | Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1. | 182 bags | Class II | Terminated | 31 May 2023 |
| D-0670-2023 | Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1. | 241 bags | Class II | Terminated | 31 May 2023 |
| D-0671-2023 | Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1. | 280 bags | Class II | Terminated | 31 May 2023 |
| D-0672-2023 | Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1. | 333 bags | Class II | Terminated | 31 May 2023 |
| D-0673-2023 | Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1. | 329 bags | Class II | Terminated | 31 May 2023 |
| D-0674-2023 | Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1. | 208 bags | Class II | Terminated | 31 May 2023 |
| D-0675-2023 | Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1. | 226 bags | Class II | Terminated | 31 May 2023 |
| D-0676-2023 | Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1. | 52 bags | Class II | Terminated | 31 May 2023 |
| D-0677-2023 | Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1. | 79 bags | Class II | Terminated | 31 May 2023 |
| D-0678-2023 | Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1. | 363 bags | Class II | Terminated | 31 May 2023 |
| D-0679-2023 | Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1. | 325 bags | Class II | Terminated | 31 May 2023 |
| D-0680-2023 | Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1. | 79 bags | Class II | Terminated | 31 May 2023 |
| D-0681-2023 | Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1. | 690 syringes | Class II | Terminated | 31 May 2023 |
| D-0682-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1. | 80 bags | Class II | Terminated | 31 May 2023 |
| D-0683-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1. | 558 bags | Class II | Terminated | 31 May 2023 |
| D-0684-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1. | 71 bags | Class II | Terminated | 31 May 2023 |
| D-0685-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1. | 138 bags | Class II | Terminated | 31 May 2023 |
| D-0686-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1. | 167 bags | Class II | Terminated | 31 May 2023 |
| D-0687-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1. | 258 bags | Class II | Terminated | 31 May 2023 |
| D-0688-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0416-1. | 139 bags | Class II | Terminated | 31 May 2023 |
| D-0689-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0418-1. | 92 bags | Class II | Terminated | 31 May 2023 |
| D-0690-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0419-1. | 418 bags | Class II | Terminated | 31 May 2023 |
| D-0691-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0420-1. | 877 bags | Class II | Terminated | 31 May 2023 |
| D-0692-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1. | 427 bags | Class II | Terminated | 31 May 2023 |
| D-0693-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0422-1. | 747 bags | Class II | Terminated | 31 May 2023 |
| D-0694-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0423-1. | 128 bags | Class II | Terminated | 31 May 2023 |
| D-0695-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1. | 135 bags | Class II | Terminated | 31 May 2023 |
| D-0696-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0427-1. | 259 bags | Class II | Terminated | 31 May 2023 |
| D-0697-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0428-1. | 485 bags | Class II | Terminated | 31 May 2023 |
| D-0698-2023 | Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1. | 328 bags | Class II | Terminated | 31 May 2023 |
| D-0699-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0430-1. | 60 bags | Class II | Terminated | 31 May 2023 |
| D-0700-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1. | 175 bags | Class II | Terminated | 31 May 2023 |
| D-0701-2023 | EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1. | 3338 bags | Class II | Terminated | 31 May 2023 |
| D-0702-2023 | oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1. | 7595 bags | Class II | Terminated | 31 May 2023 |
| D-0703-2023 | oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1. | 2624 bags | Class II | Terminated | 31 May 2023 |
| D-0704-2023 | oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1. | 2989 bags | Class II | Terminated | 31 May 2023 |
| D-0705-2023 | oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1. | 560 bags | Class II | Terminated | 31 May 2023 |
| D-0706-2023 | oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1. | 14362 bags | Class II | Terminated | 31 May 2023 |
| D-0707-2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1. | 21871 bags | Class II | Terminated | 31 May 2023 |
Showing 60 of 108 product records; the FDA enforcement report lists all of them.
Context
Other enforcement events for Central Admixture Pharmacy Services, Inc.
All 10 events for Central Admixture Pharmacy Services, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jun 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.