Multi-event February 2024 FDA Recall Drug by Contract Pharmaceuticals Limited Canada
This Multi-event Class III drug recall was voluntarily initiated by Contract Pharmaceuticals Limited Canada on February 20, 2024 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0365-2024
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
02-20-2024
03-13-2024
11,750 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Contract Pharmaceuticals Limited Canada
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S. and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Batch or Lot Expiration Information
Lot# : 119874; Exp 06/30/2025
Recall Number: D-0364-2024
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
02-20-2024
03-13-2024
45,875 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Contract Pharmaceuticals Limited Canada
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S. and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 119466, 119467 Exp 04/2025; 120351 Exp 08/2025; 121712 Exp 11/2025
