Drug product
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
D-1148-2014
Product summary
- Event
- Event 67330
- Status
- Terminated
- Classification
- Class II
- Quantity
- 161,650 vials
- Official record key
drug-enforcement:D-1148-2014
Official wording
Reason: Subpotent; 18 month time point
Code information: Lot Number: 6004137, Expiration date: 06/2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent