PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: May 2, 2018 Initiated: April 23, 2018 #D-0716-2018

Product Description

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

Reason for Recall

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

Details

Units Affected
2966 cartons
Distribution
Nationwide with the US
Location
Concord, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Mckesson Packaging Services. Units affected: 2966 cartons.
Why was this product recalled?
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 2, 2018. Severity: Low. Recall number: D-0716-2018.