FDA-Drug2018-05-02Class III

Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Hazard

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

Sold states
Nationwide with the US
Affected count
2966 cartons
Manufactured in
7101 Weddington Rd Nw, N/A, Concord, NC, United States
Products
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0716-2018

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