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.

FDA recall notice · announced January 17, 2018 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 30229439A, Exp 12/17
Quantity: 4,969 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0208-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.