PlainRecalls
FDA Drug Moderate Class II Terminated

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0575-2021

Product Description

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
235 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS. Recalled by Cardinal Health Inc.. Units affected: 235 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0575-2021.