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Recall Observatory FDA recall evidence

Drug product

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02

D-1067-2019

March 15, 2019

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 82386
Status
Terminated
Classification
Class III
Quantity
67 cartons (25 vials per carton)
Official record key
drug-enforcement:D-1067-2019

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 #: T97469, Exp. 7/2019, W28574, Exp.09/2019

Distribution pattern: Nationwide USA and Guam

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification