Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuti
Summary
The FDA issued a Class III for Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured fo by Contract Pharmaceuticals Limited Canada. Reason: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint..
Details
Source
Drug Recall
External ID
D-0364-2024
Action Date
2024-03-13
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
Quantity Affected: 45,875 bottles
Reason for Recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Distribution
Nationwide in the U.S. and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-20
Company
Mississauga
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Contract Pharmaceuticals Limited Canada has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Contract Pharmaceuticals Limited Canada) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Contract Pharmaceuticals Limited Canada have FDA actions?
Contract Pharmaceuticals Limited Canada has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0364-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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