The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0167-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Benzo/Lido/Tetracaine Topical Cream Due to Labeling Errors

KRS Global Biotechnology is recalling 3,280 jars of Benzo/Lido/Tetracaine 20%-8%-8% Topical 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. According to the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 3,280 jars of Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream. The product is a prescription-only topical cream packaged in jars. The recall was initiated due to labeling errors 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@38, 07062017@48, 08012017@23, 08212017@36, and 09182017@26. The distribution pattern for these products was nationwide in the USA, Bermuda, and New Zealand. The agency classification for this recall is Class II.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Benzo/Lido/Tetracaine 20%-8%-8% 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
3,280

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@38 BUD: 12/4/2017
  • 07062017@48 BUD: 1/2/2018
  • 08012017@23 BUD: 1/28/2018
  • 08212017@36 BUD: 2/17/2018
  • 09182017@26 BUD: 3/17/2018

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.

See all 47 products in this recall →

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