Drug recall: 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America…
Class II FDA enforcement event 71371. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
The Compounding Pharmacy of America started this drug recall on 2 Jun 2015. The firm address in the FDA record is in Knoxville, TN. FDA put the recall in Class II. FDA event 71371 has 382 product records. The first FDA enforcement report date is 23 Sep 2015. The record gives the status Terminated, with the termination date 10 Feb 2016.
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
The Compounding Pharmacy of America, Knoxville, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
382 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1431-2015 | 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | 23 ML total | Class II | Terminated | 23 Sep 2015 |
| D-1432-2015 | 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | 351 ML total | Class II | Terminated | 23 Sep 2015 |
| D-1433-2015 | Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | 250 ML total volume | Class II | Terminated | 23 Sep 2015 |
| D-1434-2015 | Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | 33 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1435-2015 | Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 99 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1436-2015 | Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | 130 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1437-2015 | Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | 24 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1438-2015 | Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | 11 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1439-2015 | Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | 76 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1440-2015 | Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | 7 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1441-2015 | L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 33 mL total | Class II | Terminated | 23 Sep 2015 |
| D-1442-2015 | Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 2923 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1443-2015 | Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 13 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1444-2015 | B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 1397 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1445-2015 | Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1446-2015 | Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN | 66 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1447-2015 | Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 44 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1448-2015 | Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 129 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1449-2015 | Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 mL | Class II | Terminated | 23 Sep 2015 |
| D-1450-2015 | Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 102 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1451-2015 | Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 33 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1452-2015 | Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN | 11 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1453-2015 | Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN | 260 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1454-2015 | Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN | 29 mL Total volume | Class II | Terminated | 23 Sep 2015 |
| D-1455-2015 | Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 35 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1456-2015 | Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 35 ML | Class II | Terminated | 23 Sep 2015 |
| D-1457-2015 | Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 6615 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1458-2015 | Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 32 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1459-2015 | Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 38 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1460-2015 | Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 33 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1461-2015 | Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 55 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1462-2015 | Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 262 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1463-2015 | DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN | 30 mL total volume | Class II | Terminated | 23 Sep 2015 |
| D-1464-2015 | Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 212 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1465-2015 | Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 98 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1466-2015 | Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 144 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1467-2015 | Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 120 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1468-2015 | Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 120 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1469-2015 | Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | 120 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1470-2015 | Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 48 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1471-2015 | Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 144 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1472-2015 | Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 10 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1473-2015 | Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 24 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1474-2015 | Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 96 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1475-2015 | Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 144 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1476-2015 | Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | 24 pellets | Class II | Terminated | 23 Sep 2015 |
| D-1477-2015 | Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 32 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1478-2015 | Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 12 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1479-2015 | Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN | 36 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1480-2015 | Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 44 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1481-2015 | Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN | 44 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1482-2015 | Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1483-2015 | Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN | 66 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1484-2015 | Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1485-2015 | Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 44 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1486-2015 | Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 65 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1487-2015 | Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1488-2015 | Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN | 129 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1489-2015 | Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN | 22 ml total volume | Class II | Terminated | 23 Sep 2015 |
| D-1490-2015 | Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN | 22 ml total volume | Class II | Terminated | 23 Sep 2015 |
The table shows 60 of 382 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 2015
- 292
- Share of these events in Class II
- 52%
- Product records in this event
- 382Median of the firm: 382
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Jan 2018 | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compou Event 79168 | Drug | Class I | 1 |
Official channels
- FDA enforcement report D-1431-2015The 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 71371. https://recallregister.com/fda/ii/71371/. 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 71371?
- The event has 382 product records. The first record gives this quantity:
23 ML total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 52% of the 292 drug events that started in 2015 are in Class II.