Recalls / Class II
Class IID-005-2014
Product
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
- Brand names
- Topcare Infants Pain And Fever, Pain And Fever, Infants Pain And Fever
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDCs
- 36800-766, 41250-766, 30142-766
- FDA application
- M013
- Affected lot / code info
- Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15
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.
Recalling firm
- Firm
- L. Perrigo Co.
- Manufacturer
- Topco Associates LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 27,504 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-01
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-005-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.