Why it was recalled
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Product description
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6
Lot numbers, UPCs & expiration codes
Lots: (Packet, Carton) 6151, 4360 Exp. 10/2021; 6240, 4446 Exp. 12/2021; 6331, 4484 Exp. 02/2022; 6413, 4551 Exp. 04/2022; 6699, 4679 Exp. 10/2022; 6751, 4714 Exp. 12/2022; 6855, 4750 Exp. 01/2023; 6868, 4761 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 7061, 4821 Exp. 05/2023.
Where it was sold
Nationwide in the USA
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-0389-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Jan 26, 2022
- Quantity
- 3,260,400 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medique Products
Original FDA data
Every field from FDA enforcement report D-0389-2022, exactly as published.
Show all FDA fields
- City
- Fort Myers
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89356
- Address
- 17080 Alico Commerce Ct Ste 1
- Code information
- Lots: (Packet, Carton) 6151, 4360 Exp. 10/2021; 6240, 4446 Exp. 12/2021; 6331, 4484 Exp. 02/2022; 6413, 4551 Exp. 04/2022; 6699, 4679 Exp. 10/2022; 6751, 4714 Exp. 12/2022; 6855, 4750 Exp. 01/2023; 6868, 4761 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 7061, 4821 Exp. 05/2023.
- Postal code
- 33967-8509
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0389-2022
- Classification
- Class II
- Recalling firm
- Medique Products
- Product quantity
- 3,260,400 tablets
- Termination date
- Jun 21, 2023
- Reason for recall
- CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2022