Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceut…

Recall date

February 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0364-2024

FDA classification

Class III

Brand / firm

Contract Pharmaceuticals Limited Canada

Sold / distributed

Nationwide in the U.S. and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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