Drug product
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
Product summary
- Event
- Event 94066
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 11,750 bottles
- Official record key
drug-enforcement:D-0365-2024
Official wording
Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Code information: Lot #: 119874; Exp 06/30/2025
Distribution pattern: Nationwide in the U.S. and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification