Recall D-0364-2024
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
Recall D-0364-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0364-2024 |
Event ID | 94066 |
Distribution | Nationwide in the U.S. and Puerto Rico |
Quantity | 45,875 bottles |
Recall Reason | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. |
Drug Classification | Class III |
Drug Code Info | 20240313 |
Recall Initiation Date | 20240220 |
Report Date | 20240313 |
Classification Date | 20240301 |
Address | 7600 East Danbro Cres Mississauga, Canada |
Recalling Firm | Contract Pharmaceuticals Limited Canada |
Initial Notification | Letter |
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