Status
Terminated
Drug Enforcement D-250-2013
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.
Classification
Class II
Report Date
April 24, 2013
Termination Date
May 7, 2015
Product Information
- 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.
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Precision Dose Inc.
- Address
-
722 Progressive Ln, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-250-2013
- Event ID
- 64676
- Recall initiation date
- March 21, 2013
- Center classification date
- April 15, 2013
- 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
- More code info
- —