Why it was recalled
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Product description
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Lot numbers, UPCs & expiration codes
Lot # P120999, Exp 07/31/2022
Where it was sold
Distributed in PA
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-0665-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 7, 2021
- FDA report date
- Jul 28, 2021
- Quantity
- 8,472 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LNK International, Inc.
Original FDA data
Every field from FDA enforcement report D-0665-2021, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 88244
- Address
- 55 Arkay Dr
- Code information
- Lot # P120999, Exp 07/31/2022
- Postal code
- 11788-3707
- Report date
- Jul 28, 2021
- Product type
- Drugs
- Recall number
- D-0665-2021
- Classification
- Class III
- Recalling firm
- LNK International, Inc.
- Product quantity
- 8,472 bottles
- Termination date
- May 4, 2023
- Reason for recall
- Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
- Distribution pattern
- Distributed in PA
- Recall initiation date
- Jul 7, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2021