Home / Recalls / Precision Dose Inc. / D-250-2013

D-250-2013 Class II Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

Recall Details

Product Type
Drugs
Report Date
April 24, 2013
Initiation Date
March 21, 2013
Termination Date
May 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,268 cases

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.

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

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

Other recalls by Precision Dose Inc.

  • D-0095-2022 Class II — Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (N (November 1, 2021)
  • D-0094-2022 Class II — Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Indivi (November 1, 2021)
  • D-0228-2021 Class II — Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dos (January 1, 2021)
  • D-1004-2020 Class II — Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case (November 13, 2019)
  • D-0057-2018 Class III — Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-3 (September 25, 2017)
  • D-1037-2017 Class II — Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, P (July 5, 2017)