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
Reported: March 13, 2024 Initiated: February 20, 2024 #D-0364-2024
Product Description
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
Reason for Recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Details
- Recalling Firm
- Contract Pharmaceuticals Limited Canada
- Units Affected
- 45,875 bottles
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Location
- Mississauga
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Contract Pharmaceuticals Limited Canada. Units affected: 45,875 bottles.
Why was this product recalled? ▼
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2024. Severity: Low. Recall number: D-0364-2024.
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