Drug 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
D-0364-2024
Product summary
- Event
- Event 94066
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 45,875 bottles
- Official record key
drug-enforcement:D-0364-2024
Official wording
Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Code information: Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Distribution pattern: Nationwide in the U.S. and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification