FDA Drug recall D-0163-2018

Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487

FDA Drug
Class II
terminated
Published 2018-01-17

On 2018-01-17 the FDA classified a Class II recall of Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487 by Krs Global Biotechnology, citing 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.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0163-2018
Classification	Class II
Status	terminated
Initiated	2017-11-16
Published	2018-01-17
Last updated	2026-09-13 11:52 UTC
Company	Krs Global Biotechnology
Distribution	US

Product

Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason

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.

Identifiers

code_info	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; 0… 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

code_info

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; 0…

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 history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.