Recalls / Class II
Class IID-0600-2024
Product
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
- Affected lot / code info
- Lot #: L200253, L200281, L200301, Exp 07/31/2024
Why it was recalled
Presence of particulate matter: glass
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 432250 vials
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2024-06-27
- FDA classified
- 2024-07-16
- Posted by FDA
- 2024-07-24
- Terminated
- 2025-09-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0600-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.