Recalls / Class III
Class IIID-1070-2019
Product
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
- Affected lot / code info
- Lot: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (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
- 701 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-1070-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.