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

FDA recall notice · announced March 13, 2024 · Contract Pharmaceuticals Limited Canada

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide in the U.S. and Puerto Rico
Lot/code information: Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Quantity: 45,875 bottles
Status: Ongoing
Products in this recall event:
- 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)
- 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 (D-0364-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.