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Recall Observatory FDA recall evidence

Drug 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

D-0430-2024

March 26, 2024

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 94280
Status
Ongoing
Classification
Class II
Quantity
6,528 bottles
Official record key
drug-enforcement:D-0430-2024

Official wording

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

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

Distribution pattern: Nationwide in the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification