Recalls / Class II
Class IID-0566-2024
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
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 0904-6730
- FDA application
- M013
- Affected lot / code info
- Lot#: 368638; Exp. 05/2025
Why it was recalled
Discoloration: Brownish tablets
Recalling firm
- Firm
- Contract Pharmacal Corporation
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Adams Ave, Hauppauge, New York 11788-3633
Distribution
- Quantity
- 14,616 bottles
- Distribution pattern
- MI
Timeline
- Recall initiated
- 2024-05-20
- FDA classified
- 2024-06-22
- Posted by FDA
- 2024-07-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0566-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.