Drug product
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
D-0940-2017
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 77545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72,575 4 mL vials
- Official record key
drug-enforcement:D-0940-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 68-104-EV; Exp 07/31/18, 73-155-EV; Exp. 12/31/18, 73-156-EV; Exp.12/31/18
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility