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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description 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.
Recall Number D-250-2013
Classification Class II
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
Product Distributed Qty 9,268 cases
Reason For Recall 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.

Event Detail

Event Id 64676
Product Type Drugs
Status Ongoing
Recalling Firm Precision Dose Inc.
City South Beloit
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-21
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico