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Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca R...

FDA Recall #D-0161-2018 — Class II — November 16, 2017

Recall #D-0161-2018 Date: November 16, 2017 Classification: Class II Status: Terminated

Product Description

Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Recalling Firm

KRS Global Biotechnology, Inc — Boca Raton, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

15,700 capsules

Distribution

Nationwide in the USA, Bermuda, and New Zealand

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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