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.
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