← FDA ENFORCEMENT
D-0364-2024Class III

Contract Pharmaceuticals Limited Canada

Recalling firm
Contract Pharmaceuticals Limited Canada
Product type
Drug
Status
Ongoing
Report date
2024-03-13
Distribution
Nationwide in the U.S. and Puerto Rico
Product quantity
45,875 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.