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
Reported: January 23, 2019 Initiated: December 19, 2018 #D-0381-2019
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
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 181,456 bottles
- Distribution
- U.S.A. nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 181,456 bottles.
Why was this product recalled? ▼
Failed dissolution specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2019. Severity: Moderate. Recall number: D-0381-2019.
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