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FDAFDA · Food and drugs·Recall number D-250-2013

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.

Published April 24, 2013 · Recall initiated: March 21, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Precision Dose Inc.
Distributor
Nationwide and Puerto Rico
Lot
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
Risk classification
Class II
Area (FDA)
drug
Country
United States

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