Class II
Terminated
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.
This recall has been terminated (originally issued January 20, 2021).
- Company
- Precision Dose Inc.
- Recall Initiated
- January 1, 2021
- Posted
- January 20, 2021
- Recall Number
- D-0228-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,107,510 unit dose cups
- Firm Location
- South Beloit, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Distribution
Nationwide USA
Lot / Code Info
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
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