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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 193005, Exp. Date 08/21
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0857-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 5472 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Contract Pharmacal Corporation
Original FDA data
Every field from FDA enforcement report D-0857-2020, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84857
- Address
- 135 Adams Ave
- Code information
- Lot #: 193005, Exp. Date 08/21
- Postal code
- 11788-3633
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0857-2020
- Classification
- Class II
- Recalling firm
- Contract Pharmacal Corporation
- Product quantity
- 5472 bottles
- Termination date
- Apr 22, 2024
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2020