D-0365-2024 Class III Ongoing
FDA drug recall D-0365-2024 was initiated by Contract Pharmaceuticals Limited Canada on Feb 20, 2024 and is designated Class III. Reason for recall: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. The recall status is ongoing. Affected quantity: 11,750 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 13, 2024
- Initiation Date
- Feb 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,750 bottles
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.
Distribution pattern
Nationwide in the U.S. and Puerto Rico
Code information
Lot #: 119874; Exp 06/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0365-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026