Recalls / Class III
Class IIID-1071-2019
Product
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
- Affected lot / code info
- Lot #: T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.
Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 8,878 cartons (25 vials per carton)
- Distribution pattern
- Nationwide USA and Guam
Timeline
- Recall initiated
- 2019-03-15
- FDA classified
- 2019-03-29
- Posted by FDA
- 2019-04-10
- Terminated
- 2022-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1071-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.