Recalls / Class II
Class IID-0941-2017
Product
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
- Affected lot / code info
- Lots: 68-105-EV; Exp. 07/31/18, 68-106-EV; Exp. 07/31/18, and 73-157-EV; Exp. 12/31/18
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Alvogen, Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- 71,825 6 mL vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-06-16
- FDA classified
- 2017-07-03
- Posted by FDA
- 2017-07-12
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0941-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.