Why it was recalled
Lack of processing controls
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 06152021@2, Exp 09/13/2021
Where it was sold
AZ, CO, FL, IL, NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0803-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 57 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Promise Pharmacy, LLC
Original FDA data
Every field from FDA enforcement report D-0803-2021, exactly as published.
Show all FDA fields
- City
- Palm Harbor
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 88662
- Address
- 31818 Us Highway 19 N
- Code information
- Lot# 06152021@2, Exp 09/13/2021
- Postal code
- 34684-3713
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0803-2021
- Classification
- Class II
- Recalling firm
- Promise Pharmacy, LLC
- Product quantity
- 57 vials
- Termination date
- Jun 6, 2023
- Reason for recall
- Lack of processing controls
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AZ, CO, FL, IL, NJ
- Recall initiation date
- Jun 30, 2021
- Initial firm notification
- Telephone
- Center classification date
- Sep 16, 2021