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Recall Observatory FDA recall evidence

Drug product

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.

D-0228-2021

January 01, 2021

Class II

Product summary

Firm
Precision Dose Inc.
Event
Event 87081
Status
Terminated
Classification
Class II
Quantity
1,107,510 unit dose cups
Official record key
drug-enforcement:D-0228-2021

Official wording

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

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

Distribution pattern: Nationwide USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations