FDA recall D-0364-2024

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.

Distribution

Nationwide in the U.S. and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2024-02-20

Report date

2024-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mississauga, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0364-2024