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Recall Observatory FDA recall evidence

Drug product

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

D-0365-2024

February 20, 2024

Class III

Product summary

Firm
Contract Pharmaceuticals Limited Canada
Event
Event 94066
Status
Ongoing
Classification
Class III
Quantity
11,750 bottles
Official record key
drug-enforcement:D-0365-2024

Official wording

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

Code information: Lot #: 119874; Exp 06/30/2025

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