Recall Enforment Report D-0425-2023
- NDC List
- Drug Recall Enforcement Reports
- Recall Enforcement Report: 91657
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Accord Healthcare, Inc., originally initiated on 02-07-2023 for the product rOPINIRole 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; 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 | Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0425-2023 | 02-07-2023 | 03-08-2023 | Class II | 139,332 bottles | rOPINIRole 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-0387-2023 | 02-07-2023 | 03-08-2023 | Class II | 69,122 bottles | Doxazosin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0428-2023 | 02-07-2023 | 03-08-2023 | Class II | 25,344 bottles | rOPINIRole 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 3 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0386-2023 | 02-07-2023 | 03-08-2023 | Class II | 44,068 bottles | Doxazosin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0389-2023 | 02-07-2023 | 03-08-2023 | Class II | 31,116 bottles | Doxazosin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0431-2023 | 02-07-2023 | 03-08-2023 | Class II | 5,112 bottles | rOPINIRole 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 4 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0430-2023 | 02-07-2023 | 03-08-2023 | Class II | 8,184 bottles | rOPINIRole 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 7 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0427-2023 | 02-07-2023 | 03-08-2023 | Class II | 104,945 bottles | rOPINIRole 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 6 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0429-2023 | 02-07-2023 | 03-08-2023 | Class II | 14,928 bottles | rOPINIRole 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 0 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0388-2023 | 02-07-2023 | 03-08-2023 | Class II | 75,190 bottles | Doxazosin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0374-2023 | 02-07-2023 | 03-08-2023 | Class II | 72,376 bottles | Atorvastatin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0376-2023 | 02-07-2023 | 03-08-2023 | Class II | 24,408 bottles | BusPIRone 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0413-2023 | 02-07-2023 | 03-08-2023 | Class II | 48,089 cartons | Succinylcholine 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 |
| D-0384-2023 | 02-07-2023 | 03-08-2023 | Class II | 113,571 bottles | Dofetilide 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 9 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0426-2023 | 02-07-2023 | 03-08-2023 | Class II | 181,848 bottles | rOPINIRole 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 9 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0414-2023 | 02-07-2023 | 03-08-2023 | Class II | 36,773 bottles | Tadalafil 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0379-2023 | 02-07-2023 | 03-08-2023 | Class II | 25,812 bottles | BusPIRone 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 2 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0393-2023 | 02-07-2023 | 03-08-2023 | Class II | 469,944 bottles | Glimepiride 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0400-2023 | 02-07-2023 | 03-08-2023 | Class II | 665,469 bottles | Montelukast 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0423-2023 | 02-07-2023 | 03-08-2023 | Class II | 120 bottles | Pravastatin 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 7 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0410-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,394,208 bottles | Simvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0419-2023 | 02-07-2023 | 03-08-2023 | Class II | 2614 cartons | Pirfenidone 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-0372-2023 | 02-07-2023 | 03-08-2023 | Class II | 241,585 bottles | Atorvastatin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0382-2023 | 02-07-2023 | 03-08-2023 | Class II | 228,760 vials | Daptomycin 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-0403-2023 | 02-07-2023 | 03-08-2023 | Class II | 37,691 vials | Phenylephrine 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 5 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0397-2023 | 02-07-2023 | 03-08-2023 | Class II | 5,273 vials | Glycopyrrolate 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 1 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0368-2023 | 02-07-2023 | 03-08-2023 | Class II | 312,864 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0381-2023 | 02-07-2023 | 03-08-2023 | Class II | 65,233 vials | Daptomycin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0412-2023 | 02-07-2023 | 03-08-2023 | Class II | 205,631 bottles | Simvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0373-2023 | 02-07-2023 | 03-08-2023 | Class II | 147,736 bottles | Atorvastatin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0399-2023 | 02-07-2023 | 03-08-2023 | Class II | 322 vials | Glycopyrrolate 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 0 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0411-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,190,484 bottles | Simvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0408-2023 | 02-07-2023 | 03-08-2023 | Class II | 256,648 bottles | Simvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0398-2023 | 02-07-2023 | 03-08-2023 | Class II | 3,164 vials | Glycopyrrolate 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 3 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0366-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,109,904 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0416-2023 | 02-07-2023 | 03-08-2023 | Class II | 176,323 bottles | Tadalafil 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0391-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,440,652 bottles | Finasteride 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 2 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0407-2023 | 02-07-2023 | 03-08-2023 | Class II | 102,360 bottles | Rosuvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0394-2023 | 02-07-2023 | 03-08-2023 | Class II | 992,622 bottles | Glimepiride 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0377-2023 | 02-07-2023 | 03-08-2023 | Class II | 10992 bottles | BusPIRone 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-0365-2023 | 02-07-2023 | 03-08-2023 | Class II | 747,464 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0421-2023 | 02-07-2023 | 03-08-2023 | Class II | 9600 bottles | Pravastatin 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0396-2023 | 02-07-2023 | 03-08-2023 | Class II | 23,814 vials | Glycopyrrolate 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 4 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0378-2023 | 02-07-2023 | 03-08-2023 | Class II | 3,784 bottles | BusPIRone 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 9 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0405-2023 | 02-07-2023 | 03-08-2023 | Class II | 56,862 bottles | Rosuvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0395-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,158,839 bottles | Glimepiride 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0420-2023 | 02-07-2023 | 03-08-2023 | Class II | 2641 bottles | Pirfenidone 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-0404-2023 | 02-07-2023 | 03-08-2023 | Class II | 63,247 bottles | Rosuvastatin 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-0417-2023 | 02-07-2023 | 03-08-2023 | Class II | 613,553 bottles | Tadalafil 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0371-2023 | 02-07-2023 | 03-08-2023 | Class II | 256,106 bottles | Atorvastatin 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-0369-2023 | 02-07-2023 | 03-08-2023 | Class II | 170,448 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0424-2023 | 02-07-2023 | 03-08-2023 | Class II | 1970 bottles | Pravastatin 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 0 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0370-2023 | 02-07-2023 | 03-08-2023 | Class II | 88,728 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0418-2023 | 02-07-2023 | 03-08-2023 | Class II | 821 cartons | Vigabatrin 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-0415-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,113,264 bottles | Tadalafil 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0390-2023 | 02-07-2023 | 03-08-2023 | Class II | 325,356 bottles | Finasteride 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0406-2023 | 02-07-2023 | 03-08-2023 | Class II | 43,302 bottles | 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0375-2023 | 02-07-2023 | 03-08-2023 | Class II | 23,784 bottles | BusPIRone 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 16729-201-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0385-2023 | 02-07-2023 | 03-08-2023 | Class II | 113,003 bottles | Dofetilide 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 6 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0380-2023 | 02-07-2023 | 03-08-2023 | Class II | 1,420,988 bottles | Clopidogrel 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, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0367-2023 | 02-07-2023 | 03-08-2023 | Class II | 539,004 bottles | Aripiprazole 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. India | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0401-2023 | 02-07-2023 | 03-08-2023 | Class II | 9,888 vials | Phenylephrine 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 6 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0409-2023 | 02-07-2023 | 03-08-2023 | Class II | 291,378 bottles | Simvastatin 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0383-2023 | 02-07-2023 | 03-08-2023 | Class II | 37,790 bottles | Dofetilide 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 2 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0402-2023 | 02-07-2023 | 03-08-2023 | Class II | 5,090 vials | Phenylephrine 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 8 | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0392-2023 | 02-07-2023 | 03-08-2023 | Class II | 2,731,365 bottles | Finasteride 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 INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Ongoing |
| D-0422-2023 | 02-07-2023 | 03-08-2023 | Class II | 32,688 bottles | Pravastatin 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 |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 16729-001 | Glimepiride | Glimepiride | Tablet | Oral | Accord Healthcare Inc | Human Prescription Drug |
| 16729-002 | Glimepiride | Glimepiride | Tablet | Oral | Accord Healthcare Inc | Human Prescription Drug |
| 16729-003 | Glimepiride | Glimepiride | Tablet | Oral | Accord Healthcare Inc | Human Prescription Drug |
| 16729-004 | Simvastatin | Simvastatin | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-005 | Simvastatin | Simvastatin | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-006 | Simvastatin | Simvastatin | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-007 | Simvastatin | Simvastatin | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-008 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-009 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-010 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-011 | Pravastatin Sodium | Pravastatin Sodium | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-044 | Atorvastatin Calcium | Atorvastatin Calcium | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-045 | Atorvastatin Calcium | Atorvastatin Calcium | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-046 | Atorvastatin Calcium | Atorvastatin Calcium | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-047 | Atorvastatin Calcium | Atorvastatin Calcium | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-089 | Finasteride | Finasteride | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-090 | Finasteride | Finasteride | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-119 | Montelukast Sodium | Montelukast Sodium | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-156 | Simvastatin | Simvastatin | Tablet, Film Coated | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-201 | Buspirone Hydrochloride | Buspirone Hydrochloride | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-202 | Buspirone Hydrochloride | Buspirone Hydrochloride | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-218 | Clopidogrel | Clopidogrel | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-219 | Clopidogrel | Clopidogrel | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-278 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-279 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-280 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-281 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-282 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-283 | Aripiprazole | Aripiprazole | Tablet | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-284 | Rosuvastatin | Rosuvastatin | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-285 | Rosuvastatin | Rosuvastatin | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-286 | Rosuvastatin | Rosuvastatin | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-287 | Rosuvastatin | Rosuvastatin | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-289 | Buspirone Hydrochloride | Buspirone Hydrochloride | Tablet | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-369 | Tadalafil | Tadalafil | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-370 | Tadalafil | Tadalafil | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-371 | Tadalafil | Tadalafil | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-372 | Tadalafil | Tadalafil | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-434 | Daptomycin | Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-435 | Daptomycin | Daptomycin | Injection, Powder, Lyophilized, For Solution | Intravenous | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-464 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Injection | Intravenous | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-465 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Injection | Intravenous | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-466 | Phenylephrine Hydrochloride | Phenylephrine Hydrochloride | Injection | Intravenous | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-467 | Pirfenidone | Pirfenidone | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-468 | Pirfenidone | Pirfenidone | Tablet, Film Coated | Oral | Accord Healthcare Inc. | Human Prescription Drug |
| 16729-471 | Glycopyrrolate | Glycopyrrolate | Injection | Intramuscular; Intravenous | Accord Healthcare, Inc., | Human Prescription Drug |
| 16729-472 | Glycopyrrolate | Glycopyrrolate | Injection | Intramuscular; Intravenous | Accord Healthcare, Inc., | Human Prescription Drug |
| 16729-473 | Glycopyrrolate | Glycopyrrolate | Injection | Intramuscular; Intravenous | Accord Healthcare, Inc., | Human Prescription Drug |
| 16729-474 | Glycopyrrolate | Glycopyrrolate | Injection | Intramuscular; Intravenous | Accord Healthcare, Inc., | Human Prescription Drug |
| 16729-490 | Dofetilide | Dofetilide | Capsule | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-491 | Dofetilide | Dofetilide | Capsule | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-492 | Dofetilide | Dofetilide | Capsule | Oral | Accord Healthcare, Inc. | Human Prescription Drug |
| 16729-493 | Succinylcholine Chloride | Succinylcholine Chloride | Injection, Solution | Intramuscular; Intravenous | Accord Healthcare, Inc. | Human Prescription Drug |
| 71713-096 | Finasteride | Finasteride | Tablet, Film Coated | Oral | Thirty Madison Inc | Human Prescription Drug |
Recall Enforcement Report D-0425-2023
Recall Enforcement Report D-0387-2023
Recall Enforcement Report D-0428-2023
Recall Enforcement Report D-0386-2023
Recall Enforcement Report D-0389-2023
Recall Enforcement Report D-0431-2023
Recall Enforcement Report D-0430-2023
Recall Enforcement Report D-0427-2023
Recall Enforcement Report D-0429-2023
Recall Enforcement Report D-0388-2023
Recall Enforcement Report D-0374-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0374-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Atorvastatin 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 72,376 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R2100461, R2100463, R2100464, Exp. Date 3/31/2023; R2101214, R2101215, R2101216, Exp. Date 9/30/2023; R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023; R2200801, Exp. Date 6/30/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-045-10; 16729-045-15; 16729-045-01; 16729-045-16; 16729-045-17; 16729-044-10; 16729-044-15; 16729-044-01; 16729-044-16; 16729-044-17; 16729-046-10; 16729-046-15; 16729-046-01; 16729-046-16; 16729-046-17; 16729-047-10; 16729-047-15; 16729-047-01; 16729-047-16; 16729-047-17 |
| Status | Ongoing |
Recall Enforcement Report D-0376-2023
Recall Enforcement Report D-0413-2023
Recall Enforcement Report D-0384-2023
Recall Enforcement Report D-0426-2023
Recall Enforcement Report D-0414-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0414-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Tadalafil 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 36,773 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 |
| Status | Ongoing |
Recall Enforcement Report D-0379-2023
Recall Enforcement Report D-0393-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0393-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Glimepiride 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 469,944 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) R2000166, Exp. Date 4/30/2023, P2003528 Exp. Date 6/30/2023, P2005451 Exp. Date 8/31/2023, P2005438 Exp. Date 8/31/2023, P2005436 Exp. Date 8/31/2023, P2005437 Exp. Date 8/31/2023, P2005452 Exp. Date 8/31/2023, P2006055 Exp. Date 9/30/2023, P2101782 Exp. Date 2/28/2024, P2101783 Exp. Date 2/28/2024, P2101781 Exp. Date 2/29/2024, P2102171 Exp. Date 2/29/2024, P2101844 Exp. Date 3/31/2024, P2101846 Exp. Date 3/31/2024, P2101845 Exp. Date 3/31/2024; b) P2006510 Exp. Date 11/30/2023, P2100975 Exp. Date 1/31/2024, P2100625 Exp. Date 1/31/2024, P2101778 Exp. Date 2/29/2024, P2101779 Exp. Date 2/29/2024, P2103021 Exp. Date 4/30/2024, P2103020 Exp. Date 4/30/2024, R2100657 Exp. Date 5/31/2024, R2100656 Exp. Date 5/31/2024, R2100658 Exp. Date 5/31/2024, P2104735 Exp. Date 7/31/2024, P2104739 Exp. Date 7/31/2024, P2104737 Exp. Date 7/31/2024, P2104738 Exp. Date 7/31/2024, P2106260 Exp. Date 9/30/2024, P2107384 Exp. Date 9/30/2024, R2200045 Exp. Date 12/31/2024, R2200046 Exp. Date 12/31/2024, R2200054 Exp. Date 12/31/2024, R2200055 Exp. Date 12/31/2024, R2200057 Exp. Date 12/31/2024, R2200058 Exp. Date 12/31/2024, R2200053 Exp. Date 12/31/2024, R2200059 Exp. Date 12/31/2024, R2200056 Exp. Date 12/31/2024, P2201929 Exp. Date 2/28/2025, R2200663 Exp. Date 4/30/2025, P2203518 Exp. Date 5/31/2025, R2200897 Exp. Date 6/30/2025, R2200898 Exp. Date 6/30/2025, R2200899 Exp. Date 6/30/2025, P2205528 Exp. Date 8/31/2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-001-01; 16729-001-16; 16729-001-17; 16729-002-01; 16729-002-16; 16729-002-17; 16729-003-01; 16729-003-16; 16729-003-17 |
| Status | Ongoing |
Recall Enforcement Report D-0400-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0400-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Montelukast 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 665,469 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) R2000831, Exp. Date 11/30/2023; R2000832, Exp. Date 11/30/2023; R2200661, Exp. Date 5/31/2025; b)R2000836, R2000837, R2000838, R2000840, R2000842, R2000835, R2000841, R2000833, Exp. Date 11/30/2023; R2100310, R2100311, R2100314, R2100312, R2100313, R2100315, R2100316, R2100317, R2100318, Exp. Date 2/29/2024; R2100859, Exp. Date 5/31/2024; R2100940, R2100993, Exp. Date 7/31/2024; c) R2000473, Exp. Date 8/31/2023; R2000517, Exp. Date 9/30/2023; R2100036, R2100005, R2100037, R2100002, R2100040, R2100044, R2100045, R2100039, R2100038, R2100104, R2100047, R2100048, R2100046, R2100049, R2100056, R2100057, R2100101, R2100058, R2100050, R2100103, R2100102, R2100116, R2100108, R2100105, R2100123, R2100117, R2100118, R2100121, R2100122, R2100128, R2100119, R2100124, Exp. Date 12/31/2023; R2100124, R2100182, R2100184, R2100183, R2100188, R2100189, R2100186, R2100222, R2100197, R2100198, R2100203, R2100192, R2100196, R2100202, R2100199, R2100200, R2100223, R2100224, R2100225, R2100226, R2100228, R2100245, R2100227, R2100230, R2100229, Exp. Date 1/31/2024; R2100246, R2100253, R2100249, R2100251, R2100248, R2100263, R2100254, R2100264, R2100265, R2100266, R2100255, R2100256, R2100257,Exp. Date 2/29/2024; R2100445, R2100446, R2100449, R2100450, R2100451, Exp. Date 3/31/2024; R2100544, R2100545, R2100549, R2100550, R2100567, R2100568, R2100574, R2100576, R2100577, Exp. Date 4/30/2024; R2100594, R2100610, R2100600, R2100624, R2100626, R2100662, R2100661, R2100629, R2100776, R2100693, R2100681, R2100684, Exp. Date 5/31/2024; R2100725, R2100724, R2100726, R2100816, R2100804, R2100815, R2100834, R2100841, Exp. Date 6/30/2024; R2200188, R2200196, R2200195, Exp. Date 1/31/2025; R2200368, R2200366, R2200503, Exp. Date 3/31/2025; R2200659, R2200660, R2200751, R2200759, R2200761, R2200763, Exp. Date 5/31/2025; R2201016, R2201014, Exp. Date 7/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-119-10; 16729-119-15; 16729-119-17 |
| Status | Ongoing |
Recall Enforcement Report D-0423-2023
Recall Enforcement Report D-0410-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0410-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Simvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,394,208 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/28/2025; b) R2000554, R2000553, Exp. Date 9/30/2023; P2100562, P2100563,Exp. Date 12/31/2023; P2100692, P2100693, P2100722, P2100761, P2100762, P2101225, P2101200, P2101148, P2101149, P2101276, P2101345, Exp. Date 1/31/2024; P2101622, P2101664, P2101638, P2101785, P2101904, Exp. Date 2/29/2024; P2101951, P2101984, P2102367, P2102369, P2102368, P2102311, P2102316, P2102406, P2102455, Exp. Date 3/31/2024; P2102553, P2102554, P2102635, P2103233, P2103253, Exp. Date 4/30/2024; P2103360, P2103322, P2103414, P2103444, P2103415, P2103447, P2103573, P2103594, P2103615, P2103679, P2103648, P2103691, P2103646, P2103629, P2103704, P2103731, P2103763, P2103788, P2103789, P2103766, P2103876, P2103959, P2103833, Exp. Date 5/31/2024; P2103992; P2104045, P2104002, P2104046, P2104381, P2104407, P2104389, P2104644, P2104409, P2104649, P2104673, P2104684, P2104743, P2104696, P2104695, P2104745, P2105154, R2100826, R2100819, R2100829, P2104697, P2104746, P2105194, R2100837, R2100830, R2100836, P2105196, P2105220, P2105195, P2105222, R2100851, R2100856, Exp. Date 6/30/2024; P2105879, P2105920, P2105937, P2105973, P2105940, P2105986, P2105997, P2106009, P2106001, P2106010, P2106159, P2106182, P2106168, P2106202, P2106203, P2106217, P2106233, P2106214, P2106245, Exp. Date 8/31/2024; P2106333, P2106327, P2106342, P2106374, P2106405, P2106416, P2106429, P2106423, P2106412, Exp. Date 9/30/2024; R2200377, R2200542, R2200543, Exp. Date 2/28/2025; P2202795, P2202420, P2202445, Exp. Date 3/31/2025; R2200598, R2200590, R2200596, R2200591, P2202817, P2203290, P2202818, P2202819, Exp. Date 4/30/2025; P2203050, P2203006, P2203051, Exp. Date 5/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 |
| Status | Ongoing |
Recall Enforcement Report D-0419-2023
Recall Enforcement Report D-0372-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0372-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Atorvastatin 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 241,585 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-045-10; 16729-045-15; 16729-045-01; 16729-045-16; 16729-045-17; 16729-044-10; 16729-044-15; 16729-044-01; 16729-044-16; 16729-044-17; 16729-046-10; 16729-046-15; 16729-046-01; 16729-046-16; 16729-046-17; 16729-047-10; 16729-047-15; 16729-047-01; 16729-047-16; 16729-047-17 |
| Status | Ongoing |
Recall Enforcement Report D-0382-2023
Recall Enforcement Report D-0403-2023
Recall Enforcement Report D-0397-2023
Recall Enforcement Report D-0368-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0368-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 312,864 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0381-2023
Recall Enforcement Report D-0412-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0412-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Simvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 205,631 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 |
| Status | Ongoing |
Recall Enforcement Report D-0373-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0373-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Atorvastatin 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 147,736 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024; R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024; R2200727, Exp. Date 5/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-045-10; 16729-045-15; 16729-045-01; 16729-045-16; 16729-045-17; 16729-044-10; 16729-044-15; 16729-044-01; 16729-044-16; 16729-044-17; 16729-046-10; 16729-046-15; 16729-046-01; 16729-046-16; 16729-046-17; 16729-047-10; 16729-047-15; 16729-047-01; 16729-047-16; 16729-047-17 |
| Status | Ongoing |
Recall Enforcement Report D-0399-2023
Recall Enforcement Report D-0411-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0411-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Simvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,190,484 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R2101339, Exp. Date 9/30/2023, R2101494, R2101495, R2101496, R2101497, Exp. Date 10/31/2023, R2200527, R2200531, Exp. Date 3/31/2024, R2200606, R2200625, Exp. Date 4/30/2024; b) P2101911, P2101913, R2100344, R2100351, R2100354, R2100346, R2100357, R2100358, R2100359, R2100361, R2100362, R2100385, R2100386, R2100388, R2100394, R2100397, R2100345, Exp. Date 2/28/2023; P2101930, P2101983, R2100435, R2100457, R2100433, R2100462, R2100466, R2100465, R2100469, R2100468, Exp. Date 3/31/2023; P2103223, P2103229, P2103234, Exp. Date 4/30/2023; P2103254, P2103258, P2103261, P2103323, P2103362, P2103364, P2103310, P2103671, P2103678, P2103545, P2103568, P2103599, P2103616, P2103627, P2103649, P2103813, P2103832, P2103834, P2103867, P2103868, P2103901, P2103912, Exp. Date 5/31/2023; P2105024, P2105027, P2105028, P2105049, P2105047, P2105052, P2105340, P2105341, P2105420, P2105432, P2105445, P2105455, P2105456, P2105467, P2105461, Exp. Date 7/31/2024; R2101118, R2101119, R2101127, R2101128, R2101134, R2101145, R2101133, R2101146, R2101149, R2101164, R2101169, R2101165, R2101187, R2101188, R2101192, R2101193, R2101168, R2101194, Exp. Date 8/31/2024; R2101516, R2101517, R2101515, R2101523, R2101525, R2101524, R2101530, R2101531, R2101532, R2101534, R2101533, R2101541, R2101547, R2101569, R2101567, R2101568, R2101571, R2101580, R2101582, R2101592, R2101583, R2101581, R2101593, P2107446, Exp. Date 10/31/2024; P2107791, P2107792, Exp. Date 11/30/2024; R2200271, R2200272, R2200275, Exp. Date 1/31/2025; R2200374, R2200379, R2200378, R2200391, Exp. Date 2/28/2025; R2200457, R2200458, R2200540, R2200470, R2200541, R2200459, R2200451, R2200471, Exp. Date 3/31/2025; R2200610, R2200611, R2200616, R2200615,R2200624, R2200628, R2200736, Exp. Date 4/30/2025, R2200688, R2200681, R2200687, Exp. Date 5/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 |
| Status | Ongoing |
Recall Enforcement Report D-0408-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0408-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Simvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 256,648 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355, Exp. Date 10/31/2023; R2200035, Exp. Date 10/31/2023; R2200515, Exp. Date 4/30/2025; R2200514, Exp. Date 4/30/2025; R2200516, Exp. Date 4/30/2025; b) R2200310, Exp Date 9/30/2023; R2101354, Exp. Date 10/31/2023; R2200513, Exp. Date 4/30/2025; R2200768, Exp. Date 5/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 |
| Status | Ongoing |
Recall Enforcement Report D-0398-2023
Recall Enforcement Report D-0366-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0366-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,109,904 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0416-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0416-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Tadalafil 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 176,323 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 |
| Status | Ongoing |
Recall Enforcement Report D-0391-2023
Recall Enforcement Report D-0407-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0407-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Rosuvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 102,360 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025; P2204337, Exp. Date 7/31/2025; P2205416, Exp. Date 8/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 |
| Status | Ongoing |
Recall Enforcement Report D-0394-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0394-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Glimepiride 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 992,622 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date 3/31/2024, P2102047 Exp. Date 3/31/2024, P2102049 Exp. Date 3/31/2024, P2102050 Exp. Date 3/31/2024, P2102051 Exp. Date 3/31/2024, P2102052 Exp. Date 3/31/2024, P2103017 Exp. Date 4/30/2024, P2103018 Exp. Date 4/30/2024, P2103900 Exp. Date 6/30/2024, P2104436 Exp. Date 6/30/2024, P2105399 Exp. Date 7/31/2024, P2105400 Exp. Date 7/31/2024, P2106257 Exp. Date 9/30/2024, P2106258 Exp. Date 9/30/2024, P2106259 Exp. Date 9/30/2024, R2101443 Exp. Date 9/30/2024, R2101445 Exp. Date 9/30/2024, R2101444 Exp. Date 9/30/2024, R2200082 Exp. Date 12/31/2024, R2200080 Exp. Date 12/31/2024, R2200079 Exp. Date 12/31/2024, R2200081 Exp. Date 12/31/2024, P2200691 Exp. Date 1/31/2025, P2200692 Exp. Date 1/31/2025, P2200693 Exp. Date 1/31/2025, P2201499 Exp. Date 2/28/2025, P2201498 Exp. Date 2/28/2025, R2200579 Exp. Date 4/30/2025, P2203881 Exp. Date 5/31/2025, P2203441 Exp. Date 5/31/2025, P2203442 Exp. Date 5/31/2025, R2200949 Exp. Date 6/30/2025, R2201094 Exp. Date 6/30/2025, R2201003 Exp. Date 7/31/2025, Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-001-01; 16729-001-16; 16729-001-17; 16729-002-01; 16729-002-16; 16729-002-17; 16729-003-01; 16729-003-16; 16729-003-17 |
| Status | Ongoing |
Recall Enforcement Report D-0377-2023
Recall Enforcement Report D-0365-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0365-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 747,464 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200430, Exp 12/31/2024; P2203333, P2203334, Exp 5/31/2025; b) P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0421-2023
Recall Enforcement Report D-0396-2023
Recall Enforcement Report D-0378-2023
Recall Enforcement Report D-0405-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0405-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Rosuvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 56,862 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2004957, Exp. Date 8/31/2023; P2004958, Exp. Date 8/31/2023; P2004959, Exp. Date 8/31/2023; P2005252, Exp. Date 9/30/2023; P2006607, Exp. Date 11/30/2023; P2101368, Exp. Date 2/29/2024; P2101777, Exp. Date 2/29/2024; P2102224, Exp. Date 3/31/2024; P2104397, Exp. Date 6/30/2024; P2104395, Exp. Date 6/30/2024; P2104398, Exp. Date 6/30/2024; P2105120, Exp. Date 7/31/2024; P2204835, Exp. Date 7/31/2025; P2204834, Exp. Date 7/31/2025; P2204837, Exp. Date 7/31/2025; P2205832, Exp. Date 9/30/2025; P2205833, Exp. Date 9/30/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 |
| Status | Ongoing |
Recall Enforcement Report D-0395-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0395-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Glimepiride 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,158,839 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2001868, Exp. Date 3/31/2023, P2001869 Exp. Date 3/31/2023, P2002810 Exp. Date 5/31/2023, P2005473 Exp. Date 8/31/2023, P2005552 Exp. Date 9/30/2023, P2101986 Exp. Date 3/31/2024, P2101989 Exp. Date 3/31/2024, P2101988 Exp. Date 3/31/2024, P2101991 Exp. Date 3/31/2024, P2101992 Exp. Date 3/31/2024, R2100736 Exp. Date 6/30/2024, R2100737 Exp. Date 6/30/2024, P2105281 Exp. Date 7/31/2024, R2101441 Exp. Date 9/30/2024, R2101454 Exp. Date 10/31/2024, R2101455 Exp. Date 10/31/2024, R2101468 Exp. Date 10/31/2024, R2101469 Exp. Date 10/31/2024, R2200096 Exp. Date 12/31/2024; b)P2005550, Exp. Date 9/30/2023, P2005549 Exp. Date 9/30/2023, P2005551 Exp. Date 9/30/2023, P2005812 Exp. Date 10/31/2023, P2005813 Exp. Date 10/31/2023, P2005970 Exp. Date 10/31/2023, P2005971 Exp. Date 10/31/2023, P2005974 Exp. Date 10/31/2023, P2005814 Exp. Date 10/31/2023, P2005972 Exp. Date 10/31/2023, P2005973 Exp. Date 10/31/2023, P2005998 Exp. Date 10/31/2023, P2005999 Exp. Date 10/31/2023, P2006001 Exp. Date 10/31/2023, P2005997 Exp. Date 10/31/2023, P2006000 Exp. Date 10/31/2023, P2100701 Exp. Date 1/31/2024, P2100702 Exp. Date 1/31/2024, P2100703 Exp. Date 1/31/2024, P2100704 Exp. Date 1/31/2024, P2102512 Exp. Date 3/31/2024, P2101993 Exp. Date 3/31/2024, P2101994 Exp. Date 3/31/2024, P2102951 Exp. Date 4/30/2024, P2102952 Exp. Date 4/30/2024, P2102953 Exp. Date 4/30/2024, P2102954 Exp. Date 4/30/2024, R2100739 Exp. Date 6/30/2024, R2100738 Exp. Date 6/30/2024, R2100740 Exp. Date 6/30/2024, P2104668 Exp. Date 6/30/2024, P2104669 Exp. Date 6/30/2024, P2104670 Exp. Date 6/30/2024, P2105283 Exp. Date 7/31/2024, P2105291 Exp. Date 7/31/2024, P2105282 Exp. Date 7/31/2024, P2105794 Exp. Date 7/31/2024, P2105292 Exp. Date 7/31/2024, P2105297 Exp. Date 7/31/2024, P2105293 Exp. Date 7/31/2024, P2105295 Exp. Date 7/31/2024, P2105294 Exp. Date 7/31/2024, R2101408 Exp. Date 9/30/2024, R2101409 Exp. Date 9/30/2024, R2101410 Exp. Date 9/30/2024, R2101411 Exp. Date 9/30/2024, R2101412 Exp. Date 9/30/2024, R2101413 Exp. Date 9/30/2024, R2200089 Exp. Date 12/31/2024, R2200097 Exp. Date 12/31/2024, R2200100 Exp. Date 12/31/2024, R2200101 Exp. Date 12/31/2024, R2200088 Exp. Date 12/31/2024, P2200775 Exp. Date 1/31/2025, P2200776 Exp. Date 1/31/2025, P2201221 Exp. Date 1/31/2025, P2201347 Exp. Date 2/28/2025, P2201348 Exp. Date 2/28/2025, R2200481 Exp. Date 3/31/2025, R2200576 Exp. Date 4/30/2025, P2203378 Exp. Date 5/31/2025, P2203379 Exp. Date 5/31/2025, P2203377 Exp. Date 5/31/2025, R2200966 Exp. Date 6/30/2025, R2200964 Exp. Date 6/30/2025, R2200973 Exp. Date 6/30/2025, P2204893 Exp. Date 8/31/2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-001-01; 16729-001-16; 16729-001-17; 16729-002-01; 16729-002-16; 16729-002-17; 16729-003-01; 16729-003-16; 16729-003-17 |
| Status | Ongoing |
Recall Enforcement Report D-0420-2023
Recall Enforcement Report D-0404-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0404-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Rosuvastatin 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. |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 63,247 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2101063, Exp. Date 1/31/2024; P2101707, Exp. Date 2/29/2024; P2203913 Exp. Date 6/30/2025; b) P2101064, Exp. Date 1/31/2024; P2101539, Exp. Date 1/31/2024; P2101709, Exp. Date 2/29/2024; P2102138, Exp. Date 2/29/2024; P2103186, Exp. Date 5/31/2024; P2104430, Exp. Date 6/30/2024; P2104703, Exp. Date 7/31/2024; P2104704, Exp. Date 7/31/2024; P2104705, Exp. Date 7/31/2024; P2104702, Exp. Date 7/31/2024; P2107176, Exp. Date 10/31/2024; P2107177, Exp. Date 10/31/2024; P2107178, Exp. Date 10/31/2024; P2107181, Exp. Date 10/31/2024; P2203915, Exp. Date 6/30/2025; P2203914, Exp. Date 6/30/2025; P2204998, Exp. Date 8/31/2025; P2204999, Exp. Date 8/31/202; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 |
| Status | Ongoing |
Recall Enforcement Report D-0417-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0417-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Tadalafil 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 613,553 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156, Exp. Date 5/31/2023; P2003154, Exp. Date 5/31/2023; P2003152, Exp. Date 5/31/2023; P2003157, Exp. Date 5/31/2023; P2003158, Exp. Date 5/31/2023; P2003159, Exp. Date 5/31/2023; P2003162, Exp. Date 5/31/2023; P2003160, Exp. Date 5/31/2023; P2003778, Exp. Date 6/30/2023; P2003779, Exp. Date 6/30/2023; P2004315, Exp. Date 6/30/2023; P2004818, Exp. Date 8/31/2023; P2004819, Exp. Date 8/31/2023; P2005158, Exp. Date 8/31/2023; P2005156, Exp. Date 8/31/2023; P2005157, Exp. Date 8/31/2023; P2005247, Exp. Date 9/30/2023; P2006641, Exp. Date 11/30/2023; P2101002, Exp. Date 1/31/2024; P2101004, Exp. Date 1/31/2024; P2101003, Exp. Date 1/31/2024; P2101006, Exp. Date 1/31/2024; P2101005, Exp. Date 1/31/2024; P2101008, Exp. Date 1/31/2024; P2101023, Exp. Date 1/31/2024; P2101022, Exp. Date 1/31/2024; P2101274, Exp. Date 2/29/2024; P2202085, Exp. Date 3/31/2025; b) P2002467, Exp. Date 4/30/2023; P2002466, Exp. Date 4/30/2023; P2002468, Exp. Date 4/30/2023; P2003780, Exp. Date 6/30/2023; P2005154, Exp. Date 8/31/2023; P2005244, Exp. Date 9/30/2023; P2005246, Exp. Date 9/30/2023; P2005809, Exp. Date 10/31/2023; P2005810, Exp. Date 10/31/2023; P2006642, Exp. Date 11/30/2023; P2006643, Exp. Date 11/30/2023; P2006644, Exp. Date 11/30/2023; P2006645, Exp. Date 11/30/2023; P2006646, Exp. Date 11/30/2023; P2006647, Exp. Date 11/30/2023; P2100463, Exp. Date 12/31/2023; P2100462, Exp. Date 12/31/2023; P2100464, Exp. Date 12/31/2023; P2100465, Exp. Date 12/31/2023; P2100498, Exp. Date 12/31/2023; P2100497, Exp. Date 12/31/2023; P2100499, Exp. Date 12/31/2023; P2100573 ,Exp. Date 1/31/2024; P2100572, Exp. Date 1/31/2024; P2100574, Exp. Date 1/31/2024; P2101007, Exp. Date 1/31/2024; P2202084, Exp. Date 3/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 |
| Status | Ongoing |
Recall Enforcement Report D-0371-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0371-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Atorvastatin 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. |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 256,106 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R2200223, Exp. Date 1/31/2024; R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024; R2200945, R2200943, Exp. Date 6/30/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-045-10; 16729-045-15; 16729-045-01; 16729-045-16; 16729-045-17; 16729-044-10; 16729-044-15; 16729-044-01; 16729-044-16; 16729-044-17; 16729-046-10; 16729-046-15; 16729-046-01; 16729-046-16; 16729-046-17; 16729-047-10; 16729-047-15; 16729-047-01; 16729-047-16; 16729-047-17 |
| Status | Ongoing |
Recall Enforcement Report D-0369-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0369-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 170,448 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0424-2023
Recall Enforcement Report D-0370-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0370-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 88,728 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0418-2023
Recall Enforcement Report D-0415-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0415-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Tadalafil 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,113,264 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041, Exp. Date 8/31/2023; P2005606, Exp. Date 9/30/2023; P2100340, Exp. Date 9/30/2023; P2100009, Exp. Date 12/31/2023; P2100010, Exp. Date 12/31/2023; P2100044, Exp. Date 12/31/2023; P2100045, Exp. Date 12/31/2023; P2100046, Exp. Date 12/31/2023; P2101129, Exp. Date 1/31/2024; P2101880, Exp. Date 1/31/2024; P2101130, Exp. Date 1/31/2024; P2101131, Exp. Date 1/31/2024; P2106689, Exp. Date 9/30/2024; P2106691, Exp. Date 9/30/2024; P2203585, Exp. Date 6/30/2025; b) P2002451 Exp. Date 4/30/2023; P2005365, Exp. Date 8/31/2023; P2005036, Exp. Date 8/31/2023; P2005037, Exp. Date 8/31/2023; P2005607, Exp. Date 9/30/2023; P2005608, Exp. Date 9/30/2023; P2100048, Exp. Date 12/31/2023; P2100052, Exp. Date 12/31/2023; P2100053, Exp. Date 12/31/2023; P2100055, Exp. Date 12/31/2023; P2100054, Exp. Date 12/31/2023; P2100387, Exp. Date 12/31/2023; P2100526, Exp. Date 12/31/2023; P2100525, Exp. Date 12/31/2023; P2100528, Exp. Date 12/31/2023; P2100530, Exp. Date 12/31/2023; P2100532, Exp. Date 12/31/2023; P2100531, Exp. Date 12/31/2023; P2100533, Exp. Date 12/31/2023; P2101127, Exp. Date 1/31/2024; P2101128, Exp. Date 1/31/2024; P2106094, Exp. Date 8/31/2024; P2106091, Exp. Date 8/31/2024; P2106093, Exp. Date 8/31/2024; P2200039, Exp. Date 9/30/2024; P2107771, Exp. Date 11/30/2024; P2107774, Exp. Date 11/30/2024; P2107772, Exp. Date 11/30/2024; P2200505, Exp. Date 12/31/2024; P2200506, Exp. Date 12/31/2024; P2200503, Exp. Date 12/31/2024; P2200510, Exp. Date 12/31/2024; P2200508, Exp. Date12/31/2024; P2203056, Exp. Date 5/31/2025; P2203058, Exp. Date 5/31/2025; P2203060, Exp. Date 5/31/2025; P2203057, Exp. Date 5/31/2025; P2203059, Exp. Date 5/31/2025; P2203584, Exp. Date 6/30/2025; P2205372, Exp. Date 8/31/2025; P2205376, Exp. Date 8/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 |
| Status | Ongoing |
Recall Enforcement Report D-0390-2023
Recall Enforcement Report D-0406-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0406-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | 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 |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 43,302 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2006560, Exp. Date 11/30/2023; P2101562, Exp. Date 2/28/2024; b) P2006561, Exp. Date 11/30/2023; P2006562, Exp. Date 11/30/2023; P2006587, Exp. Date 11/30/2023; P2100035, Exp. Date 11/30/2023; P2006600, Exp. Date 11/30/2023; P2006603, Exp. Date 11/30/2023; P2006604, Exp. Date 11/30/2023; P2006605, Exp. Date 11/30/2023; P2006606, Exp. Date 11/30/2023; P2100542, Exp. Date 12/31/2023; P2100543, Exp. Date 12/31/2023; P2100544, Exp. Date 12/31/2023; P2100545, Exp. Date 12/31/2023; P2101485, Exp. Date 2/28/2024; P2101484, Exp. Date 2/29/2024; P2205235, Exp. Date 8/31/2025; P2205236, Exp. Date 8/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 |
| Status | Ongoing |
Recall Enforcement Report D-0375-2023
Recall Enforcement Report D-0385-2023
Recall Enforcement Report D-0380-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0380-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Clopidogrel 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, INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 1,420,988 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024; b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023; c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date 4/30/2023; P2002759, P2002758, P2002755, P2002756, P2003058, P2003059, P2003061, P2003060, P2003062, P2003055, Exp. Date 5/31/2023; P2003533, P2003534, P2003535, P2003675, P2003537, P2003536, P2003676, P2003677, P2003678, P2003679, P2003680, P2003909, P2003910, Exp. Date 6/30/2023; P2004010, P2004008, P2004009, P2004232, P2004233, P2004234, Exp. Date 7/31/2023; P2004576, P2004838, R2000614, R2000624, R2000623, R2000615, R2000638, R2000637, R2000642, R2000640, Exp. Date 8/31/2023; R2000644, R2000662, R2000664, R2000643, R2000667, R2000666, R2000670, R2000671, R2000672, P2005692, P2005656, P2005693, P2005691, P2005694, Exp. Date 9/30/2023; P2005840, P2005841, P2005842, P2005843, P2005844, P2005870, P2005925, P2005923, P2005924, P2006007, P2006009, P2006010, P2005845, P2006008, P2006065, Exp. Date 10/31/2023; R2100003, R2100008, R2100010, R2100015, R2100016, R2100017, R2100018, R2100031, R2100022, R2100024, R2100069, R2100070, R2100071, R2100084, R2100080, R2100083, R2100078, R2100082, R2100093, Exp. Date 11/30/2023; P2100109, P2100304, P2100107, P2100103, P2100106, P2100108, P2100305, Exp. Date 12/31/2023; P2100718, P2100721, P2100720, P2100748, Exp. Date 1/31/2024; P2104140, Exp. Date 6/30/2024; P2104861, P2104860, P2104859, P2104866, Exp. Date 7/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-218-10; 16729-218-15; 16729-218-16; 16729-218-46; 16729-219-46; 16729-219-75 |
| Status | Ongoing |
Recall Enforcement Report D-0367-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0367-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Aripiprazole 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. India |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 539,004 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 |
| Status | Ongoing |
Recall Enforcement Report D-0401-2023
Recall Enforcement Report D-0409-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0409-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Simvastatin 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 291,378 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 |
| Status | Ongoing |
Recall Enforcement Report D-0383-2023
Recall Enforcement Report D-0402-2023
Recall Enforcement Report D-0392-2023
| Field Name | Field Value |
|---|---|
| Event ID | 91657 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number | D-0392-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern | United States including Puerto Rico and Canada What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description | Finasteride 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 INDIA |
| Reason For Recall | CGMP Deviations: recalling drug products following an FDA inspection. What is the Reason for Recall? Information describing how the product is defective. |
| Product Quantity | 2,731,365 bottles Product Quantity The amount of product subject to recall. |
| Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date | 03-08-2023 |
| Recall Initiation Date | 02-07-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type | Drugs |
| Recalling Firm | Accord Healthcare, Inc. |
| Code Info | Batches: a) P2001383, Exp. Date 2/28/2023; P2004886, Exp. Date 8/31/2023; P2100853, Exp. Date 11/30/2023; P2101652, Exp. Date 2/29/2024; P2101821, Exp. Date 2/29/2024; P2102146, Exp. Date 3/31/2024; P2107270, Exp. Date 10/31/2024; P2107939, Exp. Date 10/31/2024; P2201491, Exp. Date 2/28/2025; b) P2001377, Exp. Date 2/28/2023; P2005673, Exp. Date 9/30/2023; P2005911, Exp. Date 10/31/2023; P2005878, Exp. Date 10/31/2023; P2006076, Exp. Date 10/31/2023; P2006110,Exp. Date 10/31/2023; P2006830, Exp. Date 11/30/2023; P2100639, Exp. Date 1/31/2024; P2100640, Exp. Date 1/31/2024; P2104208, Exp. Date 6/30/2024; P2105388, Exp. Date 7/31/2024; P2105387, Exp. Date 7/31/2024; P2200316, Exp. Date 12/31/2024; P2200318, Exp. Date 12/31/2024; P2200317, Exp. Date 12/31/2024; P2200319, Exp. Date 12/31/2024; P2200820, Exp. Date 1/31/2025; P2200822, Exp. Date 1/31/2025; P2201492, Exp. Date 2/28/2025; P2201493, Exp. Date 2/28/2025; P2201758, Exp. Date 2/28/2025; P2201759, Exp. Date 2/28/2025; P2202107, Exp. Date 3/31/2025; c) P2001375, Exp. Date 2/28/2023; P2003258, Exp. Date 5/31/2023; P2005402, Exp. Date 9/30/2023; P2005497, Exp. Date 9/30/2023; P2100511, Exp. Date 12/31/2023; P2101047, Exp. Date 1/31/2024; P2104753, Exp. Date 6/30/2024; P2105389, Exp. Date 7/31/2024; P2107273, Exp. Date 10/31/2024; P2107276, Exp. Date 10/31/2024; P2107419, Exp. Date 10/31/2024; P2201757, Exp. Date 2/28/2025; d)P2001376, Exp. Date 2/28/2023; P2002182, Exp. Date 3/31/2023; P2002184, Exp. Date 3/31/2023; P2003254, Exp. Date 5/31/2023; P2003255, Exp. Date 5/31/2023; P2003256, Exp. Date 5/31/2023; P2003257, Exp. Date 5/31/2023; P2004403, Exp. Date 7/31/2023; P2004404, Exp. Date 7/31/2023; P2004416, Exp. Date 7/31/2023; P2004417, Exp. Date 7/31/2023; P2004526, Exp. Date 7/31/2023; P2004527, Exp. Date 7/31/2023; P2004841, Exp. Date 8/31/2023; P2004842, Exp. Date 8/31/2023; P2004885, Exp. Date 8/31/2023; P2004899, Exp. Date 8/31/2023; P2004901, Exp. Date 8/31/2023; P2005406, Exp. Date 9/30/2023; P2005498, Exp. Date 9/30/2023; P2005671, Exp. Date 9/30/2023; P2005675, Exp. Date 9/30/2023; P2005672, Exp. Date 9/30/2023; P2005860, Exp. Date 10/31/2023; P2006077, Exp. Date 10/31/2023; P2006079, Exp. Date 10/31/2023; P2006125, Exp. Date 10/31/2023; P2006081, Exp. Date 10/31/2023; P2006111, Exp. Date 10/31/2023; P2006832, Exp. Date 11/30/2023; P2006831, Exp. Date 11/30/2023; P2006833, Exp. Date 11/30/2023; P2006834, Exp. Date 11/30/2023; P2006835, Exp. Date 11/30/2023; P2100266, Exp. Date 12/31/2023; P2100268, Exp. Date 12/31/2023; P2100269, Exp. Date 12/31/2023; P2100637, Exp. Date 1/31/2024; P2100636, Exp. Date 1/31/2024; P2100638, Exp. Date 1/31/2024; P2100795, Exp. Date 1/31/2024; P2100797, Exp. Date 1/31/2024; P2100803, Exp. Date 1/31/2024; P2101048, Exp. Date 1/31/2024; P2100794, Exp. Date 1/31/2024; P2100796, Exp. Date 1/31/2024; P2101403, Exp. Date 2/28/2024; P2101404, Exp. Date 2/28/2024; P2101819, Exp. Date 2/28/2024; P2101653, Exp. Date 2/29/2024; P2101654, Exp. Date 2/29/2024; P2101818, Exp. Date 2/29/2024; P2101820, Exp. Date 2/29/2024; P2102022, Exp. Date 3/31/2024; P2102023, Exp. Date 3/31/2024; P2102024, Exp. Date 3/31/2024; P2102025, Exp. Date 3/31/2024; P2102026, Exp. Date 3/31/2024; P2102096, Exp. Date 3/31/2024; P2102097, Exp. Date 3/31/2024; P2102098, Exp. Date 3/31/2024; P2102145, Exp. Date 3/31/2024; P2102293, Exp. Date 3/31/2024; P2102294, Exp. Date 3/31/2024; P2102295, Exp. Date 3/31/2024; P2103218, Exp. Date 3/31/2024; P2102296, Exp. Date 3/31/2024; P2103063, Exp. Date 5/31/2024; P2103062, Exp. Date 5/31/2024; P2103064, Exp. Date 5/31/2024; P2103065, Exp. Date 5/31/2024; P2106836, Exp. Date 7/31/2024; P2106015, Exp. Date 8/31/2024; P2106017, Exp. Date 8/31/2024; P2106016, Exp. Date 8/31/2024; P2106020, Exp. Date 8/31/2024; P2106018, Exp. Date 8/31/2024; P2106019, Exp. Date 8/31/2024; P2106596, Exp. Date 9/30/2024; P2106597, Exp. Date 9/30/2024; P2106599, Exp. Date 9/30/2024; P2106598, Exp. Date 9/30/2024; P2106601, Exp. Date 9/30/2024; P2107420, Exp. Date 10/31/2024; P2107421, Exp. Date 10/31/2024; P2107423, Exp. Date 10/31/2024; P2107636, Exp. Date 11/30/2024; P2107635, Exp. Date 11/30/2024; P2107637, Exp. Date 11/30/2024; P2107638, Exp. Date 11/30/2024; P2107640, Exp. Date 11/30/2024; P2107641, Exp. Date 11/30/2024; P2107642, Exp. Date 11/30/2024; P2107756, Exp. Date 11/30/2024; P2107757, Exp. Date 11/30/2024; P2107840, Exp. Date 11/30/2024; P2107758, Exp. Date 11/30/2024; P2107841, Exp. Date 11/30/2024; P2107844, Exp. Date 11/30/2024; P2107843, Exp. Date 11/30/2024; P2107900, Exp. Date 11/30/2024; P2107902, Exp. Date 11/30/2024; P2107903, Exp. Date 11/30/2024; P2200313, Exp. Date 12/31/2024; P2200314, Exp. Date 12/31/2024; P2200823, Exp. Date 1/31/2025; P2200824, Exp. Date 1/31/2025; P2200825, Exp. Date 1/31/2025; P2201048, Exp. Date 1/31/2025; P2201049, Exp. Date 1/31/2025; P2201055, Exp. Date 1/31/2025; P2201051, Exp. Date 1/31/2025; P2201053, Exp. Date 1/31/2025; P2201494, Exp. Date 2/28/2025; P2201754, Exp. Date 2/28/2025; P2201755, Exp. Date 2/28/2025; P2202210, Exp. Date 2/28/2025; P2202235, Exp. Date 2/28/2025; P2201756, Exp. Date 2/28/2025; P2203018, Exp. Date 5/31/2025; P2203017, Exp. Date 5/31/2025; P2203015, Exp. Date 5/31/2025; P2203019, Exp. Date 5/31/2025; P2204008, Exp. Date 6/30/2025; P2204378, Exp. Date 6/30/2025; P2204010, Exp. Date 6/30/2025; P2204073, Exp. Date 6/30/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages | 16729-090-10; 16729-090-15; 16729-090-01; 16729-090-16; 16729-090-17 |
| Status | Ongoing |