FDA-Drug2024-05-01Class II

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.

Glenmark Pharmaceuticals Inc., USA
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA.
Affected count
3,264 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.

Official notice

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

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