D-0208-2018 Class II Terminated
FDA drug recall D-0208-2018 was initiated by Teva Pharmaceuticals USA on December 14, 2017 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing. The recall status is terminated (terminated October 1, 2018). Affected quantity: 4,969 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- October 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,969 bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 30229439A, Exp 12/17