Recall Enforment Report D-0406-2023

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Accord Healthcare, Inc., originally initiated on 02-07-2023 for the product Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA The product was recalled due to cgmp deviations: recalling drug products following an fda inspection.. The product was distributed in United States Including Puerto Rico And Canada and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0406-202302-07-202303-08-2023Class II43,302 bottlesRosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0420-202302-07-202303-08-2023Class II2641 bottlesPirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0419-202302-07-202303-08-2023Class II2614 cartonsPirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0368-202302-07-202303-08-2023Class II312,864 bottlesAripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0369-202302-07-202303-08-2023Class II170,448 bottlesAripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0428-202302-07-202303-08-2023Class II25,344 bottlesrOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0427-202302-07-202303-08-2023Class II104,945 bottlesrOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0388-202302-07-202303-08-2023Class II75,190 bottlesDoxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0399-202302-07-202303-08-2023Class II322 vialsGlycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 0CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0392-202302-07-202303-08-2023Class II2,731,365 bottlesFinasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0397-202302-07-202303-08-2023Class II5,273 vialsGlycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2 ML vial NDC 16729-472-30 UPC 3 16729 47230 2; carton NDC 16729-472-08 UPC 3 16729 47208 1CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0387-202302-07-202303-08-2023Class II69,122 bottlesDoxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0430-202302-07-202303-08-2023Class II8,184 bottlesrOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0398-202302-07-202303-08-2023Class II3,164 vialsGlycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0389-202302-07-202303-08-2023Class II31,116 bottlesDoxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0426-202302-07-202303-08-2023Class II181,848 bottlesrOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0386-202302-07-202303-08-2023Class II44,068 bottlesDoxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0400-202302-07-202303-08-2023Class II665,469 bottlesMontelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0381-202302-07-202303-08-2023Class II65,233 vialsDaptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0382-202302-07-202303-08-2023Class II228,760 vialsDaptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0396-202302-07-202303-08-2023Class II23,814 vialsGlycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0391-202302-07-202303-08-2023Class II1,440,652 bottlesFinasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0418-202302-07-202303-08-2023Class II821 cartonsVigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0390-202302-07-202303-08-2023Class II325,356 bottlesFinasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0425-202302-07-202303-08-2023Class II139,332 bottlesrOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2;CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0431-202302-07-202303-08-2023Class II5,112 bottlesrOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0429-202302-07-202303-08-2023Class II14,928 bottlesrOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0373-202302-07-202303-08-2023Class II147,736 bottlesAtorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0371-202302-07-202303-08-2023Class II256,106 bottlesAtorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0374-202302-07-202303-08-2023Class II72,376 bottlesAtorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0410-202302-07-202303-08-2023Class II1,394,208 bottlesSimvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0372-202302-07-202303-08-2023Class II241,585 bottlesAtorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0412-202302-07-202303-08-2023Class II205,631 bottlesSimvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0409-202302-07-202303-08-2023Class II291,378 bottlesSimvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0411-202302-07-202303-08-2023Class II1,190,484 bottlesSimvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0408-202302-07-202303-08-2023Class II256,648 bottlesSimvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0370-202302-07-202303-08-2023Class II88,728 bottlesAripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0416-202302-07-202303-08-2023Class II176,323 bottlesTadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0404-202302-07-202303-08-2023Class II63,247 bottlesRosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0385-202302-07-202303-08-2023Class II113,003 bottlesDofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 6CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0380-202302-07-202303-08-2023Class II1,420,988 bottlesClopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0378-202302-07-202303-08-2023Class II3,784 bottlesBusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 9CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0375-202302-07-202303-08-2023Class II23,784 bottlesBusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-201-01CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0424-202302-07-202303-08-2023Class II1970 bottlesPravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0393-202302-07-202303-08-2023Class II469,944 bottlesGlimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0394-202302-07-202303-08-2023Class II992,622 bottlesGlimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0365-202302-07-202303-08-2023Class II747,464 bottlesAripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0384-202302-07-202303-08-2023Class II113,571 bottlesDofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0395-202302-07-202303-08-2023Class II1,158,839 bottlesGlimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0366-202302-07-202303-08-2023Class II1,109,904 bottlesAripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0414-202302-07-202303-08-2023Class II36,773 bottlesTadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0405-202302-07-202303-08-2023Class II56,862 bottlesRosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0377-202302-07-202303-08-2023Class II10992 bottlesBusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0407-202302-07-202303-08-2023Class II102,360 bottlesRosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0367-202302-07-202303-08-2023Class II539,004 bottlesAripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. IndiaCGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0383-202302-07-202303-08-2023Class II37,790 bottlesDofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0376-202302-07-202303-08-2023Class II24,408 bottlesBusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0423-202302-07-202303-08-2023Class II120 bottlesPravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0415-202302-07-202303-08-2023Class II1,113,264 bottlesTadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0417-202302-07-202303-08-2023Class II613,553 bottlesTadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0421-202302-07-202303-08-2023Class II9600 bottlesPravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0379-202302-07-202303-08-2023Class II25,812 bottlesBusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0422-202302-07-202303-08-2023Class II32,688 bottlesPravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0403-202302-07-202303-08-2023Class II37,691 vialsPhenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0401-202302-07-202303-08-2023Class II9,888 vialsPhenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0402-202302-07-202303-08-2023Class II5,090 vialsPhenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton NDC 16729-465-03, UPC 3 16729 46503 8CGMP Deviations: recalling drug products following an FDA inspection.Ongoing
D-0413-202302-07-202303-08-2023Class II48,089 cartonsSuccinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.CGMP Deviations: recalling drug products following an FDA inspection.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
16729-001Glimepiride GlimepirideTabletOralAccord Healthcare IncHuman Prescription Drug
16729-002Glimepiride GlimepirideTabletOralAccord Healthcare IncHuman Prescription Drug
16729-003Glimepiride GlimepirideTabletOralAccord Healthcare IncHuman Prescription Drug
16729-004Simvastatin SimvastatinTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-005Simvastatin SimvastatinTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-006Simvastatin SimvastatinTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-007Simvastatin SimvastatinTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-008Pravastatin Sodium Pravastatin SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-009Pravastatin Sodium Pravastatin SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-010Pravastatin Sodium Pravastatin SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-011Pravastatin Sodium Pravastatin SodiumTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-044Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-045Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-046Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-047Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-089Finasteride FinasterideTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-090Finasteride FinasterideTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-119Montelukast Sodium Montelukast SodiumTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-156Simvastatin SimvastatinTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-200Buspirone Hydrochloride Buspirone HydrochlorideTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-201Buspirone Hydrochloride Buspirone HydrochlorideTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-202Buspirone Hydrochloride Buspirone HydrochlorideTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-203Buspirone Hydrochloride Buspirone HydrochlorideTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-211Doxazosin DoxazosinTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-213Doxazosin DoxazosinTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-218Clopidogrel ClopidogrelTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-219Clopidogrel ClopidogrelTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-232Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-233Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-234Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-235Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-236Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-237Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-238Ropinirole RopiniroleTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-278Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-279Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-280Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-281Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-282Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-283Aripiprazole AripiprazoleTabletOralAccord Healthcare, Inc.Human Prescription Drug
16729-284Rosuvastatin RosuvastatinTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-285Rosuvastatin RosuvastatinTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-286Rosuvastatin RosuvastatinTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-287Rosuvastatin RosuvastatinTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-289Buspirone Hydrochloride Buspirone HydrochlorideTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-369Tadalafil TadalafilTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-370Tadalafil TadalafilTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-371Tadalafil TadalafilTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-372Tadalafil TadalafilTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-414Doxazosin DoxazosinTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-415Doxazosin DoxazosinTabletOralAccord Healthcare Inc.Human Prescription Drug
16729-434Daptomycin DaptomycinInjection, Powder, Lyophilized, For SolutionIntravenousAccord Healthcare, Inc.Human Prescription Drug
16729-435Daptomycin DaptomycinInjection, Powder, Lyophilized, For SolutionIntravenousAccord Healthcare Inc.Human Prescription Drug
16729-464Phenylephrine Hydrochloride Phenylephrine HydrochlorideInjectionIntravenousAccord Healthcare, Inc.Human Prescription Drug
16729-465Phenylephrine Hydrochloride Phenylephrine HydrochlorideInjectionIntravenousAccord Healthcare, Inc.Human Prescription Drug
16729-466Phenylephrine Hydrochloride Phenylephrine HydrochlorideInjectionIntravenousAccord Healthcare, Inc.Human Prescription Drug
16729-467Pirfenidone PirfenidoneTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-468Pirfenidone PirfenidoneTablet, Film CoatedOralAccord Healthcare Inc.Human Prescription Drug
16729-471Glycopyrrolate GlycopyrrolateInjectionIntramuscular; IntravenousAccord Healthcare, Inc.,Human Prescription Drug
16729-472Glycopyrrolate GlycopyrrolateInjectionIntramuscular; IntravenousAccord Healthcare, Inc.,Human Prescription Drug
16729-473Glycopyrrolate GlycopyrrolateInjectionIntramuscular; IntravenousAccord Healthcare, Inc.,Human Prescription Drug
16729-474Glycopyrrolate GlycopyrrolateInjectionIntramuscular; IntravenousAccord Healthcare, Inc.,Human Prescription Drug
16729-490Dofetilide DofetilideCapsuleOralAccord Healthcare, Inc.Human Prescription Drug
16729-491Dofetilide DofetilideCapsuleOralAccord Healthcare, Inc.Human Prescription Drug
16729-492Dofetilide DofetilideCapsuleOralAccord Healthcare, Inc.Human Prescription Drug
16729-493Succinylcholine Chloride Succinylcholine ChlorideInjection, SolutionIntramuscular; IntravenousAccord Healthcare, Inc.Human Prescription Drug
71713-096Finasteride FinasterideTablet, Film CoatedOralThirty Madison IncHuman Prescription Drug