FDAClass IIIMarch 13, 2024

Clindamycin Phosphate recall

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

Why was Clindamycin Phosphate recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Contract Pharmaceuticals Limited Canada
Quantity
45,875 bottles
Distribution
Nationwide in the U.S. and Puerto Rico
Recall date
March 13, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls