KRS Global Biotechnology Recalls Benzocaine Cream Due to Labeling Errors
KRS Global Biotechnology is recalling 4,530 jars of Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.
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 and involves a labeling error regarding expiration dates, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 4,530 jars of Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream. The product is a prescription-only cream packaged in jars. The recall is due to a labeling issue where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected lots are 06072017@22, 06222017@30, 08032017@31, 09212017@21, and 10232017@20. The products were distributed nationwide in the USA, Bermuda, and New Zealand. The agency has classified this as a Class II recall.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 4,530
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 (5)
- Lots: 06072017@22 BUD: 12/4/2017
- 06222017@30 BUD: 12/19/2017
- 08032017@31 BUD: 1/30/2018
- 09212017@21 BUD: 3/20/2018
- 10232017@20 BUD: 11/22/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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