Precision Dose Recalls Chlorhexidine Gluconate Oral Rinse Due to cGMP Deviations
Precision Dose Inc. is recalling Chlorhexidine Gluconate Oral Rinse USP 0.12% unit dose cups due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source text cites cGMP deviations without reporting specific illnesses or injuries, aligning with the 'Moderate' severity criteria for voluntary precautionary recalls or minor labeling/quality errors.
Plain-English summary
Precision Dose Inc. is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP 0.12% packaged in 15 mL unit dose cups. The recall involves two specific NDC codes: 68094-028-61 (30-pack cases) and 68094-028-62 (100-pack cases). The affected product is prescription-only and was distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. The firm was notified of the manufacturer's expanded recall. The source text does not specify the exact nature of the cGMP deviations, nor does it report any illnesses, injuries, or deaths associated with the use of this product.
Consumers and healthcare providers should discontinue use of the affected lots and return them to the point of purchase or contact Precision Dose Inc. for further instructions. The affected lots include specific expiration dates ranging from January 2021 to February 2022, as detailed in the recall notice.
The recalled product
- 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.
- Manufacturer
- Precision Dose Inc.
- Category
- Drug — Oral Rinse
- Hazard
- Affected units
- 1,107,510
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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