May 2024 FDA Recall Acetaminophen by Contract Pharmacal Corporation
D-0566-2024 - Discoloration
This Class II drug recall was voluntarily initiated by Contract Pharmacal Corporation on May 20, 2024 for the product Acetaminophen. The FDA reported the reason for recall as discoloration. The product was distributed in MI and the recall is currently ongoing.
Recall Number: D-0566-2024
Discoloration: Brownish tablets
05-20-2024
07-03-2024
14,616 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 Pharmacal Corporation
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.
MI
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
Batch or Lot Expiration Information
Lot# : 368638; Exp. 05/2025
