Why it was recalled
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Product description
Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2
Lot numbers, UPCs & expiration codes
Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15
Where it was sold
Nationwide
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-005-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 27,504 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- L. Perrigo Co.
Original FDA data
Every field from FDA enforcement report D-005-2014, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 66711
- Address
- 515 Eastern Ave
- Code information
- Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15
- Postal code
- 49010-9070
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-005-2014
- Classification
- Class II
- Recalling firm
- L. Perrigo Co.
- Product quantity
- 27,504 bottles
- Termination date
- Apr 15, 2014
- Reason for recall
- Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 1, 2013
- Initial firm notification
- Press Release
- Center classification date
- Nov 20, 2013