Recalls / Class III
Class IIID-0766-2022
Product
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.
- Brand name
- Cyanocobalamin
- Generic name
- Cyanocobalamin
- Active ingredient
- Cyanocobalamin
- Route
- Intramuscular
- NDC
- 55150-364
- FDA application
- ANDA213874
- Affected lot / code info
- Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Why it was recalled
Subpotent Drug: Out of Specification results for Assay
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- AuroMedics Pharma LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 433,809 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-04-05
- FDA classified
- 2022-04-12
- Posted by FDA
- 2022-04-20
- Terminated
- 2024-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0766-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.