The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0161-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Anastrozole 0.5 mg Capsules for Labeling Errors

KRS Global Biotechnology is recalling 15,700 capsules of Anastrozole 0.5 mg due to incorrect or missing lot and expiration dates.

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 15,700 capsules of Anastrozole 0.5 mg, a prescription-only medication. The recall was initiated because the product labels contain incorrect or missing lot and/or expiration dates. Specifically, the Beyond Use Date (BUD) listed on the packaging exceeds the expiration date of at least one ingredient used to manufacture the final product.

The affected products were distributed nationwide in the United States, as well as in Bermuda and New Zealand. The recall covers specific lots with Beyond Use Dates ranging from March 9, 2018, to October 29, 2018.

Consumers and healthcare providers should stop using the recalled Anastrozole 0.5 mg capsules and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
15,700

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 (14)

  • Lots: 03092017@21 BUD: 3/9/2018
  • 03292017@33 BUD: 3/24/2018
  • 05092017@38 BUD: 5/4/2018
  • 05162017@31 BUD: 5/11/2018
  • 05182017@25 BUD: 5/13/2018
  • 07032017@40 BUD: 6/28/2018
  • 07142017@34 BUD: 7/9/2018
  • 07192017@32 BUD: 7/14/2018
  • 08282017@25 BUD: 8/23/2018
  • 09142017@8BUD: 9/9/2018
  • 09212017@23 BUD: 9/16/2018
  • 09272017@36 BUD: 9/ 22/2018
  • 10162017@39 BUD: 10/11/2018
  • 11032017@28 BUD: 10/29/2018

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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