Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Product description
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
Lot numbers, UPCs & expiration codes
Batch: 1CK1146, Exp 02/28/2023
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-0591-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 26, 2021
- FDA report date
- Mar 2, 2022
- Quantity
- 26,832 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0591-2022, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 88905
- Address
- 515 Eastern Ave
- Code information
- Batch: 1CK1146, Exp 02/28/2023
- Postal code
- 49010-9070
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0591-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 26,832 bottles
- Termination date
- Sep 29, 2023
- Reason for recall
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2022