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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0364-2024
Event ID94066
DistributionNationwide in the U.S. and Puerto Rico
Quantity45,875 bottles
Recall ReasonDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Drug ClassificationClass III
Drug Code Info20240313
Recall Initiation Date20240220
Report Date20240313
Classification Date20240301
Address7600 East Danbro Cres
Mississauga,  
Canada
Recalling FirmContract Pharmaceuticals Limited Canada
Initial Notification Letter
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