Recalls / Class II
Class IID-250-2013
Product
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
- Affected lot / code info
- Lot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14
Why it was recalled
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Recalling firm
- Firm
- Precision Dose Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, N/A, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 9,268 cases
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-03-21
- FDA classified
- 2013-04-15
- Posted by FDA
- 2013-04-24
- Terminated
- 2015-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-250-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.