Drug recall: Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Class II FDA enforcement event 82554. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of sterility assurance.
Class II, in the words of FDA
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
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy started this drug recall on 2 Apr 2019. The firm address in the FDA record is in Bristol, TN. FDA put the recall in Class II. FDA event 82554 has 68 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 24 Sep 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, Bristol, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
68 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1137-2019 | Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN. | 10 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1138-2019 | Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Unknown | Class II | Terminated | 24 Apr 2019 |
| D-1139-2019 | Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN. | 5 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1140-2019 | Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1141-2019 | Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN. | 3 vials | Class II | Terminated | 24 Apr 2019 |
| D-1142-2019 | DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 syringe | Class II | Terminated | 24 Apr 2019 |
| D-1143-2019 | Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 35 vials | Class II | Terminated | 24 Apr 2019 |
| D-1144-2019 | Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 6 syringes | Class II | Terminated | 24 Apr 2019 |
| D-1145-2019 | Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 4 bottles | Class II | Terminated | 24 Apr 2019 |
| D-1146-2019 | HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 vial | Class II | Terminated | 24 Apr 2019 |
| D-1147-2019 | HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 9 vials | Class II | Terminated | 24 Apr 2019 |
| D-1148-2019 | HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 217 vials | Class II | Terminated | 24 Apr 2019 |
| D-1149-2019 | HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 31 vials | Class II | Terminated | 24 Apr 2019 |
| D-1150-2019 | HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890 | 57 vials | Class II | Terminated | 24 Apr 2019 |
| D-1151-2019 | HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 99 vials | Class II | Terminated | 24 Apr 2019 |
| D-1152-2019 | HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 vial | Class II | Terminated | 24 Apr 2019 |
| D-1153-2019 | HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890 | 14 vials | Class II | Terminated | 24 Apr 2019 |
| D-1154-2019 | HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 vial | Class II | Terminated | 24 Apr 2019 |
| D-1155-2019 | HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 2 vials | Class II | Terminated | 24 Apr 2019 |
| D-1156-2019 | Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 2 syringes | Class II | Terminated | 24 Apr 2019 |
| D-1157-2019 | Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 syringe | Class II | Terminated | 24 Apr 2019 |
| D-1158-2019 | Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 syringe | Class II | Terminated | 24 Apr 2019 |
| D-1159-2019 | Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 12 syringes | Class II | Terminated | 24 Apr 2019 |
| D-1160-2019 | Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 6 syringes | Class II | Terminated | 24 Apr 2019 |
| D-1161-2019 | Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 276 vails | Class II | Terminated | 24 Apr 2019 |
| D-1162-2019 | Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 vials | Class II | Terminated | 24 Apr 2019 |
| D-1163-2019 | Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1164-2019 | Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 60 vials | Class II | Terminated | 24 Apr 2019 |
| D-1165-2019 | Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 vial | Class II | Terminated | 24 Apr 2019 |
| D-1166-2019 | Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 1 vial | Class II | Terminated | 24 Apr 2019 |
| D-1167-2019 | Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1168-2019 | Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 23 vials | Class II | Terminated | 24 Apr 2019 |
| D-1169-2019 | Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 6 vials | Class II | Terminated | 24 Apr 2019 |
| D-1170-2019 | Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 vials | Class II | Terminated | 24 Apr 2019 |
| D-1171-2019 | Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 40 vials | Class II | Terminated | 24 Apr 2019 |
| D-1172-2019 | Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 vials | Class II | Terminated | 24 Apr 2019 |
| D-1173-2019 | Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 58 vials | Class II | Terminated | 24 Apr 2019 |
| D-1174-2019 | Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 31 vials | Class II | Terminated | 24 Apr 2019 |
| D-1175-2019 | Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 22 vials | Class II | Terminated | 24 Apr 2019 |
| D-1176-2019 | Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 6 vials | Class II | Terminated | 24 Apr 2019 |
| D-1177-2019 | Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 40 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1178-2019 | Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 60 drop containers | Class II | Terminated | 24 Apr 2019 |
| D-1179-2019 | Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 10 syringes | Class II | Terminated | 24 Apr 2019 |
| D-1180-2019 | Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 2 vials | Class II | Terminated | 24 Apr 2019 |
| D-1181-2019 | Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 5 vials | Class II | Terminated | 24 Apr 2019 |
| D-1182-2019 | Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | 4 vials | Class II | Terminated | 24 Apr 2019 |
| D-1183-2019 | Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1184-2019 | Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1185-2019 | Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1186-2019 | Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1187-2019 | Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1188-2019 | Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1189-2019 | EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1190-2019 | Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1191-2019 | Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1192-2019 | Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1193-2019 | Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1194-2019 | Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1195-2019 | Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
| D-1196-2019 | HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | N/A | Class II | Terminated | 24 Apr 2019 |
The table shows 60 of 68 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2019
- 362
- Share of these events in Class II
- 68%
- Product records in this event
- 68
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1137-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82554. https://recallregister.com/fda/ii/82554/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 82554?
- The event has 68 product records. The first record gives this quantity:
10 drop containers
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2019 have the same class?
- 68% of the 362 drug events that started in 2019 are in Class II.