Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed...
FDA Recall #D-0364-2024 — Class III — February 20, 2024
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
Reason for Recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recalling Firm
Contract Pharmaceuticals Limited Canada — Mississauga
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
45,875 bottles
Distribution
Nationwide in the U.S. and Puerto Rico
Code Information
Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated