Recall Enforment Report D-0715-2018

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Mckesson Packaging Services, originally initiated on 04-23-2018 for the product Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10 The product was recalled due to failed dissolution specifications. high dissolution results were obtained during stability testing.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0715-201804-23-201805-02-2018Class III7656 cartonsDiltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10Failed Dissolution Specifications. High dissolution results were obtained during stability testing.Terminated
D-0716-201804-23-201805-02-2018Class III2966 cartonsDiltiazem 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: 63739-016-10Failed Dissolution Specifications. High dissolution results were obtained during stability testing.Terminated
D-0714-201804-23-201805-02-2018Class III4266 cartonsDiltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10Failed Dissolution Specifications. High dissolution results were obtained during stability testing.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
63739-014Diltiazem Hydrochloride Extended-ReleaseDiltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralMckesson Corporation Dba Sky PackagingHuman Prescription Drug
63739-015Diltiazem Hydrochloride Extended-ReleaseDiltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralMckesson Corporation Dba Sky PackagingHuman Prescription Drug
63739-016Diltiazem Hydrochloride Extended-ReleaseMckesson Corporation Dba Sky Packaging