Recalls / Class II
Class IID-0858-2020
Product
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 0904-6730
- FDA application
- M013
- Affected lot / code info
- Lot #: 193005, Exp. Date 08/21
Why it was recalled
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
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
- a) 1176 bottles b) 6,216 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-02-03
- FDA classified
- 2020-02-27
- Posted by FDA
- 2020-02-19
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0858-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.