Clindamycin Phosphate recall — Class III (D-0364-2024) · pharmaranks
Class IIIOngoing
Clindamycin Phosphate recall
FDA recall D-0364-2024 · initiated Feb 20, 2024
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Details
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 company
Contract Pharmaceuticals Limited Canada
Classification
Class III
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the U.S. and Puerto Rico
Initiated
Feb 20, 2024
FDA report date
Mar 13, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.