Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Reported: November 15, 2023 Initiated: October 23, 2023 #D-0092-2024
Product Description
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 16,944 bottles
- Distribution
- Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 16,944 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0092-2024.
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