Drug Enforcement D-0364-2024

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Status

Ongoing

Classification

Class III

Report Date

March 13, 2024

Termination Date

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Product Information

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
Product quantity
45,875 bottles
Reason for recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S. and Puerto Rico

Location & Firm

Recalling firm
Contract Pharmaceuticals Limited Canada
Address
7600 East Danbro Cres

Canada
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0364-2024
Event ID
94066
Recall initiation date
February 20, 2024
Center classification date
March 1, 2024
Code info
Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
More code info
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