Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca ...
FDA Recall #D-0163-2018 — Class II — November 16, 2017
Product Description
Anastrozole SR 1 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
22,520 capsules
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 02022017@30 BUD: 1/28/2018; 04172017@29 BUD: 4/12/2018; 05082017@39 BUD: 5/3/2018; 05222017@23 BUD: 5/17/2018; 06072017@28 BUD: 6/2/2018; 06122017@42 BUD: 6/7/2018; 06192017@24 BUD: 6/14/2018; 06292017@25 BUD: 6/24/2018; 07112017@33 BUD: 7/6/2018; 07172017@35 BUD: 7/12/2018; 07282017@26 BUD: 7/23/2018; 08012017@25 BUD: 7/27/2018; 08112017@35 BUD: 8/9/2018; 08142017@30 BUD: 8/9/2018; 08172017@31 BUD: 8/12/2018; 09202017@21 BUD: 9/15/2018; 09142017@27 BUD: 9/9/2018; 10022017@38 BUD: 3/31/2018; 10102017@37 BUD: 4/8/2018; 10172017@26 BUD: 4/15/2018; 10202017@22 BUD: 4/18/2018; 10302017@29 BUD: 4/28/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated