Home / Recalls / Precision Dose Inc. / D-0228-2021

D-0228-2021 Class II Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

Recall Details

Product Type
Drugs
Report Date
January 20, 2021
Initiation Date
January 1, 2021
Termination Date
July 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,107,510 unit dose cups

Product Description

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

Reason for Recall

cGMP deviations: The firm was notified of the manufacturer's expanded recall.

Distribution Pattern

Nationwide USA

Code Information

Lot #: a) 502037, 502040, 502043, Exp 1/31/2021; 502494, 502757, Exp 8/31/2021; 502677, Exp 9/30/2021; 502693, 502728, Exp 10/31/2021; 502771, 502784, Exp 11/30/2021; 502824, Exp 12/31/2021; 502925, Exp 2/28/2022; b) 502037, 502040, 502043, Exp 1/31/2021; 502494, Exp 8/31/2021; 502759, Exp 10/31/2021; 502771, Exp 11/30/2021

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-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)
  • D-250-2013 Class II — Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6809 (March 21, 2013)