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Recall Observatory FDA recall evidence

Drug product

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01

D-1068-2019

March 15, 2019

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 82386
Status
Terminated
Classification
Class III
Quantity
820 cartons (25 vials per carton)
Official record key
drug-enforcement:D-1068-2019

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#: T78191, Exp.04/2019, T97494, Exp.07/2019

Distribution pattern: Nationwide USA and Guam

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification