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.
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 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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