Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0487-2023 | 02-08-2023 | Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25 | Lack of assurance of sterility: Suspected microbial growth present on external label packaging. | Apollo Care / 215 bags | Class II | Ongoing |
| D-0380-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 1,420,988 bottles | Class II | Terminated |
| D-0430-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 8,184 bottles | Class II | Terminated |
| D-0386-2023 | 02-07-2023 | 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 Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 44,068 bottles | Class II | Terminated |
| D-0387-2023 | 02-07-2023 | 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 Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 69,122 bottles | Class II | Terminated |
| D-0389-2023 | 02-07-2023 | 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 Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 31,116 bottles | Class II | Terminated |
| D-0418-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 821 cartons | Class II | Terminated |
| D-0403-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 37,691 vials | Class II | Terminated |
| D-0413-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 48,089 cartons | Class II | Terminated |
| D-0400-2023 | 02-07-2023 | 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 Package NDCs: 16729-119-10; 16729-119-15; 16729-119-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 665,469 bottles | Class II | Terminated |
| D-0402-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 5,090 vials | Class II | Terminated |
| D-0401-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 9,888 vials | Class II | Terminated |
| D-0368-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 312,864 bottles | Class II | Terminated |
| D-0379-2023 | 02-07-2023 | 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 Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 25,812 bottles | Class II | Terminated |
| D-0369-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 170,448 bottles | Class II | Terminated |
| D-0411-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,190,484 bottles | Class II | Terminated |
| D-0419-2023 | 02-07-2023 | 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. Package NDCs: 16729-468-15; 16729-468-64; 16729-467-15; 16729-467-85; 16729-467-64 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 2614 cartons | Class II | Terminated |
| D-0414-2023 | 02-07-2023 | 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 Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 36,773 bottles | Class II | Terminated |
| D-0417-2023 | 02-07-2023 | 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 Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 613,553 bottles | Class II | Terminated |
| D-0415-2023 | 02-07-2023 | 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 Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,113,264 bottles | Class II | Terminated |
| D-0392-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 2,731,365 bottles | Class II | Terminated |
| D-0391-2023 | 02-07-2023 | 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. | Accord Healthcare, Inc. / 1,440,652 bottles | Class II | Terminated |
| D-0375-2023 | 02-07-2023 | 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 Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 23,784 bottles | Class II | Terminated |
| D-0385-2023 | 02-07-2023 | 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 Package NDCs: 16729-490-12; 16729-490-59; 16729-491-12; 16729-491-59; 16729-492-12; 16729-492-59 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 113,003 bottles | Class II | Terminated |
| D-0406-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 43,302 bottles | Class II | Terminated |
| D-0424-2023 | 02-07-2023 | 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 Package NDCs: 16729-008-15; 16729-008-16; 16729-008-17; 16729-009-15; 16729-009-16; 16729-009-17; 16729-010-15; 16729-010-16; 16729-010-17; 16729-011-15; 16729-011-16; 16729-011-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1970 bottles | Class II | Terminated |
| D-0371-2023 | 02-07-2023 | 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. Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 256,106 bottles | Class II | Terminated |
| D-0426-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 181,848 bottles | Class II | Terminated |
| D-0390-2023 | 02-07-2023 | 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 Package NDCs: 16729-089-10; 16729-089-15 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 325,356 bottles | Class II | Terminated |
| D-0429-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 14,928 bottles | Class II | Terminated |
| D-0388-2023 | 02-07-2023 | 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 Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 75,190 bottles | Class II | Terminated |
| D-0431-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 5,112 bottles | Class II | Terminated |
| D-0425-2023 | 02-07-2023 | 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; Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 139,332 bottles | Class II | Terminated |
| D-0428-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 25,344 bottles | Class II | Terminated |
| D-0427-2023 | 02-07-2023 | 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 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 104,945 bottles | Class II | Terminated |
| D-0384-2023 | 02-07-2023 | 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 Package NDCs: 16729-490-12; 16729-490-59; 16729-491-12; 16729-491-59; 16729-492-12; 16729-492-59 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 113,571 bottles | Class II | Terminated |
| D-0423-2023 | 02-07-2023 | 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 Package NDCs: 16729-008-15; 16729-008-16; 16729-008-17; 16729-009-15; 16729-009-16; 16729-009-17; 16729-010-15; 16729-010-16; 16729-010-17; 16729-011-15; 16729-011-16; 16729-011-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 120 bottles | Class II | Terminated |
| D-0372-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 241,585 bottles | Class II | Terminated |
| D-0397-2023 | 02-07-2023 | 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 Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05; 16729-472-30 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 5,273 vials | Class II | Terminated |
| D-0421-2023 | 02-07-2023 | 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 Package NDCs: 16729-008-15; 16729-008-16; 16729-008-17; 16729-009-15; 16729-009-16; 16729-009-17; 16729-010-15; 16729-010-16; 16729-010-17; 16729-011-15; 16729-011-16; 16729-011-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 9600 bottles | Class II | Terminated |
| D-0366-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,109,904 bottles | Class II | Terminated |
| D-0395-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,158,839 bottles | Class II | Terminated |
| D-0407-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 102,360 bottles | Class II | Terminated |
| D-0381-2023 | 02-07-2023 | 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 Package NDCs: 16729-434-05; 16729-434-45 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 65,233 vials | Class II | Terminated |
| D-0408-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 256,648 bottles | Class II | Terminated |
| D-0416-2023 | 02-07-2023 | 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 Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 176,323 bottles | Class II | Terminated |
| D-0376-2023 | 02-07-2023 | 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 Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 24,408 bottles | Class II | Terminated |
| D-0374-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 72,376 bottles | Class II | Terminated |
| D-0410-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,394,208 bottles | Class II | Terminated |
| D-0409-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 291,378 bottles | Class II | Terminated |
| D-0367-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 539,004 bottles | Class II | Terminated |
| D-0383-2023 | 02-07-2023 | 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 Package NDCs: 16729-490-12; 16729-490-59; 16729-491-12; 16729-491-59; 16729-492-12; 16729-492-59 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 37,790 bottles | Class II | Terminated |
| D-0422-2023 | 02-07-2023 | 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. Package NDCs: 16729-008-15; 16729-008-16; 16729-008-17; 16729-009-15; 16729-009-16; 16729-009-17; 16729-010-15; 16729-010-16; 16729-010-17; 16729-011-15; 16729-011-16; 16729-011-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 32,688 bottles | Class II | Terminated |
| D-0399-2023 | 02-07-2023 | 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 Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 322 vials | Class II | Terminated |
| D-0365-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 747,464 bottles | Class II | Terminated |
| D-0405-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 56,862 bottles | Class II | Terminated |
| D-0373-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 147,736 bottles | Class II | Terminated |
| D-0378-2023 | 02-07-2023 | 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 Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 3,784 bottles | Class II | Terminated |
| D-0398-2023 | 02-07-2023 | 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 Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05; 16729-473-31 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 3,164 vials | Class II | Terminated |
| D-0370-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 88,728 bottles | Class II | Terminated |
| D-0404-2023 | 02-07-2023 | 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. Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 63,247 bottles | Class II | Terminated |
| D-0412-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 205,631 bottles | Class II | Terminated |
| D-0394-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 992,622 bottles | Class II | Terminated |
| D-0377-2023 | 02-07-2023 | 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; Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 10992 bottles | Class II | Terminated |
| D-0396-2023 | 02-07-2023 | 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 Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05; 16729-471-63 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 23,814 vials | Class II | Terminated |
| D-0393-2023 | 02-07-2023 | 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 Package NDCs: 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 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 469,944 bottles | Class II | Terminated |
| D-0382-2023 | 02-07-2023 | 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. Package NDCs: 16729-435-05 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 228,760 vials | Class II | Terminated |
| D-0420-2023 | 02-07-2023 | 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. Package NDCs: 16729-468-15; 16729-468-64; 16729-467-15; 16729-467-85; 16729-467-64 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 2641 bottles | Class II | Terminated |
| D-0353-2023 | 02-06-2023 | Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90. | Sub-Potent Drug: Out of specification for assay at the 24 month interval. | Alvogen, Inc / 21,276 bottles | Class II | Terminated |
| D-0327-2023 | 02-03-2023 | Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41 | Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. | Leadiant Biosciences, Inc. / 31,879 vials | Class II | Terminated |
| D-0329-2023 | 02-02-2023 | Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01 Package NDCs: 16864-670-01 | Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. | Advantice Health, Llc / 16,152 cans/673 cases | Class III | Terminated |
| D-0351-2023 | 02-01-2023 | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 7,740 kg polyethylene lined fiber drums, boxes & sacks | Class III | Terminated |
| D-0352-2023 | 02-01-2023 | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 106,560 kg. polyethylene lined fiber drums, boxes & sacks | Class III | Terminated |
| D-0349-2023 | 02-01-2023 | Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 131,060 kg. polyethylene lined fiber drums, boxes & sacks | Class III | Terminated |
| D-0350-2023 | 02-01-2023 | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 368,980 kg polyethylene lined fiber drums, boxes & sacks | Class III | Terminated |
| D-0268-2023 | 01-31-2023 | Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11. Package NDCs: 70377-038-11 | Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. | BIOCON PHARMA INC / 3665 bottles | Class II | Terminated |
| D-0920-2023 | 01-30-2023 | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15. | CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated. | Global Pharma Healthcare Private Limited / 400,008 bottles total for all products | Class II | Ongoing |
| D-0919-2023 | 01-30-2023 | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15. | Non-Sterility: FDA analysis found unopened products to have bacterial contamination. | Global Pharma Healthcare Private Limited / 400,008 bottles total for all products | Class I | Ongoing |
| D-0921-2023 | 01-30-2023 | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15. | Non-Sterility: FDA analysis found unopened products to have bacterial contamination. | Global Pharma Healthcare Private Limited / 400,008 bottles total for all products | Class I | Ongoing |
| D-0922-2023 | 01-30-2023 | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15. | CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated. | Global Pharma Healthcare Private Limited / 400,008 bottles total for all products | Class II | Ongoing |
| D-0336-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0112-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0345-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0160-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0331-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0105-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0344-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0150-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0337-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0113-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0338-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0115-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0340-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0120-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0333-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0140-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0342-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0334-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0155-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0332-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0130-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0343-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0145-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0339-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0117-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0341-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0125-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0335-2023 | 01-30-2023 | TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0110-5 Package NDCs: 71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2 | Subpotent Drug | IBSA PHARMA INC / N/A | Class II | Terminated |
| D-0265-2023 | 01-30-2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02 | Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. | Akorn, Inc. / 45,117 Bottles | Class III | Ongoing |
| D-0436-2023 | 01-27-2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11. | Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values. | Amerisource Health Services LLC / 422 cartons | Class II | Terminated |
| D-0174-2023 | 01-20-2023 | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03 Package NDCs: 68180-956-01; 68180-956-02; 68180-956-03; 68180-956-04 | Subpotent Drug: Low assay result observed during long-term stability testing. | Lupin Pharmaceuticals Inc. / 5720 tubes | Class III | Terminated |
| D-0163-2023 | 01-17-2023 | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410. | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC / a) 1077 bottles, b) 52 cases | Class II | Ongoing |
| D-0164-2023 | 01-17-2023 | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410. | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC / 106 bottles | Class II | Ongoing |
