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Recall Observatory FDA recall evidence

Drug 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

D-1071-2019

March 15, 2019

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 82386
Status
Terminated
Classification
Class III
Quantity
8,878 cartons (25 vials per carton)
Official record key
drug-enforcement:D-1071-2019

Official wording

Reason: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Code information: Lot #: T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.

Distribution pattern: Nationwide USA and Guam

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification