D-0381-2019 Class II Terminated
FDA drug recall D-0381-2019 was initiated by Teva Pharmaceuticals USA on Dec 19, 2018 and is designated Class II. Reason for recall: Failed dissolution specifications The recall status is terminated (terminated Aug 31, 2020). Affected quantity: 181,456 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 23, 2019
- Initiation Date
- Dec 19, 2018
- Termination Date
- Aug 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 181,456 bottles
Product Description
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
Reason for Recall
Failed dissolution specifications
Distribution Pattern
U.S.A. nationwide
Code Information
Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0381-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026