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Is Diltiazem recalled?

52 FDA recalls mention Diltiazem. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Diltiazem.

Class III · Low risk Terminated Feb 13, 2019

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles…

Reason Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Mylan Pharmaceuticals Inc. NDC 0378-5280-01 D-0506-2019

Class III · Low risk Terminated Jan 30, 2019

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant…

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time…

Valeant Pharmaceuticals North America LLC NDC 68682-521-01 D-0491-2019

Class III · Low risk Terminated Jan 30, 2019

Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC…

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time…

Valeant Pharmaceuticals North America LLC NDC 0187-0798-30 D-0490-2019

Class III · Low risk Terminated Jan 30, 2019

Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC…

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time…

Valeant Pharmaceuticals North America LLC NDC 0187-0797-30 D-0489-2019

Class III · Low risk Terminated Jan 30, 2019

Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC…

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time…

Valeant Pharmaceuticals North America LLC NDC 0187-0796-30 D-0488-2019

Class III · Low risk Terminated Jan 30, 2019

Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC…

Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time…

Valeant Pharmaceuticals North America LLC NDC 0187-0795-30 D-0487-2019

Class III · Low risk Terminated Aug 14, 2018

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only…

Reason Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-947-08 D-1112-2018

Class III · Low risk Terminated Aug 7, 2018

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505…

Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Mylan Pharmaceuticals Inc. NDC 0378-5220-05 D-1187-2018

Class III · Low risk Terminated Aug 7, 2018

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505…

Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Mylan Pharmaceuticals Inc. NDC 0378-5220-01 D-1186-2018

Class II · Moderate risk Terminated Jun 14, 2018

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC…

Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

SCA Pharmaceuticals, LLC D-0897-2018

Class III · Low risk Terminated Apr 23, 2018

Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd…

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

Mckesson Packaging Services D-0716-2018

Class III · Low risk Terminated Apr 23, 2018

Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60…

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

Mckesson Packaging Services NDC 63739-284-10 D-0715-2018

Class III · Low risk Terminated Apr 23, 2018

Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd…

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

Mckesson Packaging Services D-0714-2018

Class II · Moderate risk Terminated Oct 10, 2017

Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W…

Reason Lack of Assurance of Sterility.

Banner Pharmacy Services, LLC D-0015-2018

Class II · Moderate risk Terminated Jul 14, 2017

Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR…

Reason Lack of Sterility Assurance.

Cantrell Drug Company NDC 52533-103-13 D-1073-2017

Class II · Moderate risk Terminated Jul 14, 2017

Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA…

Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

SCA Pharmaceuticals D-1002-2017

Class II · Moderate risk Terminated Feb 22, 2017

Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Advanced Pharma Inc. D-0824-2017

Class III · Low risk Terminated Nov 3, 2016

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx…

Reason Failed Impurities/Degradation Specifications: OOS results for known compound.

Mylan Pharmaceuticals Inc. NDC 0378-5220-01 D-0151-2017

Class II · Moderate risk Terminated Apr 20, 2016

Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN…

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0853-02 D-1309-2016

Class II · Moderate risk Terminated Mar 25, 2016

All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1118-2016

Class III · Low risk Terminated Mar 26, 2015

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by…

Reason Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Actavis Laboratories, FL, Inc. NDC 62037-0600-90 D-0488-2015

Class III · Low risk Terminated Jul 3, 2014

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only…

Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-947-08 D-1435-2014

Class III · Low risk Terminated Jun 19, 2014

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV…

Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Mylan Pharmaceuticals Inc. NDC 0378-5220-05 D-1557-2014

Class II · Moderate risk Terminated Jul 2, 2013

DILTIAZEM HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093032101.

Reason Labeling: Label Mixup: DILTIAZEM HCL, Tablet, 120 mg, may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2…

Aidapak Services, LLC D-824-2014

Class II · Moderate risk Terminated Jul 2, 2013

DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109

Reason Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769…

Aidapak Services, LLC D-589-2014