Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Reported: August 30, 2023 Initiated: August 14, 2023 #D-1095-2023
Product Description
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Reason for Recall
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 1,200 bottles
- Distribution
- nationwide in the U.S.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 1,200 bottles.
Why was this product recalled? ▼
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Low. Recall number: D-1095-2023.
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