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Recall Observatory FDA recall evidence

Drug product

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

D-0364-2024

February 20, 2024

Class III

Product summary

Firm
Contract Pharmaceuticals Limited Canada
Event
Event 94066
Status
Ongoing
Classification
Class III
Quantity
45,875 bottles
Official record key
drug-enforcement:D-0364-2024

Official wording

Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Code information: Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025

Distribution pattern: Nationwide in the U.S. and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification