Drug Enforcement D-0430-2024

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Status

Ongoing

Classification

Class II

Report Date

April 10, 2024

Termination Date

—

Product Information

Product description
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
Product quantity
6,528 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0430-2024
Event ID
94280
Recall initiation date
March 26, 2024
Center classification date
April 2, 2024
Code info
Lot #: 17230304, Exp. 12/31/2024.
More code info
—