Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharma...
FDA Recall #D-0365-2024 — Class III — February 20, 2024
Product Description
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Reason for Recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recalling Firm
Contract Pharmaceuticals Limited Canada — Mississauga
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,750 bottles
Distribution
Nationwide in the U.S. and Puerto Rico
Code Information
Lot #: 119874; Exp 06/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated