KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredients
KRS Global Biotechnology is recalling 1,380 jars of Benzocaine, Lidocaine, and Tetracaine Topical Cream because the product's beyond-use date exceeds the expiration dates of its ingredients.
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 and low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 1,380 jars of Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream. The product is prescription-only and was distributed nationwide in the USA, Bermuda, and New Zealand.
The recall was initiated due to a labeling issue where the Beyond Use Date (BUD) of the final product exceeds the expiration dates of at least one ingredient used in its manufacture. The affected lots are 07142017@31 (BUD: 1/10/2018), 09202017@22 (BUD: 3/19/2018), and 10042017@25 (BUD: 4/2/2018).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical 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
- 1,380
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 (3)
- Lots: 07142017@31 BUD: 1/10/2018
- 09202017@22 BUD: 3/19/2018
- 10042017@25 BUD: 4/2/2018
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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