Recalls / Class II
Class IID-0857-2020
Product
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8
- 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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Adams Ave, Hauppauge, New York 11788-3633
Distribution
- Quantity
- 5472 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-0857-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.