Recalls / Class I
Class ID-0600-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot: 01052018@46 Use By: 2/9/2018
Why it was recalled
Non-Sterility
Recalling firm
- Firm
- The Compounding Pharmacy of America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6216 Highland Place Way Ste 101-A, Knoxville, Tennessee 37919-4068
Distribution
- Quantity
- 5 vials
- Distribution pattern
- TN, SC
Timeline
- Recall initiated
- 2018-01-12
- FDA classified
- 2018-03-14
- Posted by FDA
- 2018-02-21
- Terminated
- 2021-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0600-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.