PlainRecalls
FDA Drug Moderate Class II Terminated

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

Reported: January 17, 2018 Initiated: December 14, 2017 #D-0208-2018

Product Description

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
4,969 bottles
Distribution
Nationwide in the USA
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.. Recalled by Teva Pharmaceuticals USA. Units affected: 4,969 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0208-2018.