Drug 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.
D-0600-2024
Product summary
- Event
- Event 94914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 432250 vials
- Official record key
drug-enforcement:D-0600-2024
Official wording
Reason: Presence of particulate matter: glass
Code information: Lot #: L200253, L200281, L200301, Exp 07/31/2024
Distribution pattern: TN
Derived failure modes
-
Foreign material or chemical contamination
particulate matter