March 2024 FDA Recall Diltiazem Hydrochloride by Glenmark Pharmaceuticals Inc., Usa
D-0430-2024 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on March 26, 2024 for the product Diltiazem Hydrochloride. 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-0430-2024

Reason for Recall
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Initiated
03-26-2024
Reported
04-10-2024
Quantity
6,528 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94280
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01

Batch or Lot Expiration Information

Lot# : 17230304, Exp. 12/31/2024.

Affected Packages Involved in this Recall

68462-850-01 Diltiazem Hydrochloride
68462-851-01 Diltiazem Hydrochloride
68462-562-01 Diltiazem Hydrochloride