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
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Lot numbers, UPCs & expiration codes
Lots: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023
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-0391-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Jan 26, 2022
- Quantity
- 6,639,838 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medique Products
Original FDA data
Every field from FDA enforcement report D-0391-2022, 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: 6492 Exp. 06/2022; 6701 Exp. 10/2022; 6750 Exp. 12/2022; 6853 Exp. 01/2023; 6854 Exp. 01/2023; 6869 Exp. 02/2023; 6898 Exp. 02/2023; 6901 Exp. 02/2023; 7059 Exp. 05/2023; 7060 Exp. 05/2023; 7064 Exp. 06/2023; 7065 Exp. 06/2023
- Postal code
- 33967-8509
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0391-2022
- Classification
- Class II
- Recalling firm
- Medique Products
- Product quantity
- 6,639,838 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
- Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2022