CLASS I Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection recalled
The Compounding Pharmacy of America is recalling HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection, Multi-Dose Vial, Sterile, distributed in South Carolina, Tennessee. The recall was initiated on 12 Jan 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0600-2018
- FDA event ID
- 79168
- Recalling firm
- The Compounding Pharmacy of America, Knoxville, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 14 Mar 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 21 Feb 2018 | Published in enforcement report | +40 days |
| 14 Mar 2018 | Classified by FDA | +21 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Where it was distributed
TN, SC
Questions about this recall
Why was it recalled?
Non-Sterility
Which lots are affected?
Lot: 01052018@46 Use By: 2/9/2018
Where was it sold?
TN, SC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Compounding Pharmacy of America
All 383| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol 4 mg, Sterile Pellet recalled by The Compounding Pharmacy of | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 62.5 mg Pellet, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
Other Hcg 5 recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection recalled | The Compounding Pharmacy of America | Sterility | Nationwide |