Medichem Recalls Chlorhexidine Gluconate 20% Due to Discoloration
Medichem S.A. is voluntarily recalling 60,000 kg of Chlorhexidine Gluconate 20% in Alabama, New Jersey, and Texas due to discoloration.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the reason is discoloration, which is a minor labeling or quality defect without reported illness or injury, fitting the Moderate criteria for minor errors or low-risk issues.
Plain-English summary
Medichem S.A. is voluntarily recalling 60,000 kg of Chlorhexidine Gluconate 20% (NDC 53296-0012-0) because of discoloration. The affected product is identified by specific batch numbers, including A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, and A-200398.
The recall was initiated by the firm on October 2, 2020, and was classified as Class II by the FDA. The product was distributed in Alabama, New Jersey, and Texas. The recall was terminated on December 16, 2020.
Healthcare providers and consumers should check their inventory for the specific batch numbers listed above. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
- Manufacturer
- Medichem S.A.
- Category
- Drug — Antiseptic
- Hazard
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 (12)
- Batch: A-200301
- A-200307
- A-200308
- A-200309
- A-200395
- A-200488
- A-200310
- A-200311
- A-200315
- A-200319
- A-200397
- A-200398
Distribution
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