Home / Recalls / Precision Dose Inc. / D-0057-2018

D-0057-2018 Class III Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

Recall Details

Product Type
Drugs
Report Date
November 8, 2017
Initiation Date
September 25, 2017
Termination Date
April 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
801 cases

Product Description

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.

Reason for Recall

Subpotent Drug: low out of specification results.

Distribution Pattern

Nationwide in the USA

Code Information

Lot number: 500105, Exp 04/30/18

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-1037-2017 Class II — Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, P (July 5, 2017)
  • D-250-2013 Class II — Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6809 (March 21, 2013)