Recalls / Class II
Class IID-0803-2021
Product
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
- Affected lot / code info
- Lot# 06152021@2, Exp 09/13/2021
Why it was recalled
Lack of processing controls
Recalling firm
- Firm
- Promise Pharmacy, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 31818 Us Highway 19 N, N/A, Palm Harbor, Florida 34684-3713
Distribution
- Quantity
- 57 vials
- Distribution pattern
- AZ, CO, FL, IL, NJ
Timeline
- Recall initiated
- 2021-06-30
- FDA classified
- 2021-09-16
- Posted by FDA
- 2021-09-22
- Terminated
- 2023-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0803-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.