FDA recall D-0472-2024

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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2024-04-17

Report date

2024-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2024