Why it was recalled
Subpotent Drug: Out of Specification results for Assay
Product description
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Lot numbers, UPCs & expiration codes
Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Where it was sold
Nationwide in the USA.
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-0766-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 5, 2022
- FDA report date
- Apr 20, 2022
- Quantity
- 433,809 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0766-2022, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89941
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
- Postal code
- 08520-1401
- Report date
- Apr 20, 2022
- Product type
- Drugs
- Recall number
- D-0766-2022
- Classification
- Class III
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 433,809 vials
- Termination date
- Jun 27, 2024
- Reason for recall
- Subpotent Drug: Out of Specification results for Assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 5, 2022
- Center classification date
- Apr 12, 2022