FDA Recall D-0566-2024
Contract Pharmacal Corporation · Hauppauge, NY
Class II Ongoing 724 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Discoloration: Brownish tablets
Recall record
- Recall number
D-0566-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- MI
- Recall initiated
- 2024-05-20
- Classified by FDA Center
- 2024-06-22
- FDA published
- 2024-07-03
- Recalling firm
- Contract Pharmacal Corporation
- Firm location
- Hauppauge, NY
Drug identification
- Brand name(s)
- ACETAMINOPHEN
- Generic name(s)
- ACETAMINOPHEN
- Manufacturer(s)
- Major Pharmaceuticals
- NDC(s)
0904-6730- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.