October 2023 FDA Recall Ranolazine by Glenmark Pharmaceuticals Inc., Usa
D-0092-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on October 23, 2023 for the product Ranolazine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0092-2024
Failed Dissolution Specifications: Out of specification for dissolution.
10-23-2023
11-15-2023
16,944 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# 17230388, Exp. 01/31/2025
