Drug Enforcement D-0472-2024

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

May 1, 2024

Termination Date

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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
3,264 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0472-2024
Event ID
94440
Recall initiation date
April 17, 2024
Center classification date
April 25, 2024
Code info
Lot #: 17221312, Exp. 5/31/2024
More code info
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