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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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. Package NDCs: 47781-640-90; 47781-640-10; 47781-643-90; 47781-643-10; 47781-646-90; 47781-646-10; 47781-649-90; 47781-649-10; 47781-651-90; 47781-651-10; 47781-654-90; 47781-654-10; 47781-657-90; 47781-657-10; 47781-659-90; 47781-659-10; 47781-662-90; 47781-662-10; 47781-665-90; 47781-665-10; 47781-668-90; 47781-668-10; 47781-671-90; 47781-671-10 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| 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-0263-2023 | 01-17-2023 | Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power / a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles | Class II | Terminated |
| D-0264-2023 | 01-17-2023 | Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power / 609 bottles | Class II | Terminated |
| D-0173-2023 | 01-16-2023 | Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09. | Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet. | Preferred Pharmaceuticals, Inc. / 9 bottles | Class II | Terminated |
| D-0176-2023 | 01-13-2023 | S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9 Package NDCs: 0487-5901-99 | Short Fill | Nephron Sc Inc / 925,920 vials | Class II | Terminated |
| D-0175-2023 | 01-13-2023 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4 | Short Fill | Nephron Sc Inc / 387,000 vials | Class II | Terminated |
| D-0172-2023 | 01-13-2023 | FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01. | Short Fill: Underfilled units. | OurPharma LLC / 768 cassettes | Class III | Terminated |
| D-0262-2023 | 01-13-2023 | Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81 Package NDCs: 47335-675-83; 47335-675-81; 47335-675-19; 47335-675-13; 47335-675-18; 47335-676-83; 47335-676-81; 47335-676-19; 47335-676-13; 47335-676-18; 47335-677-83; 47335-677-81; 47335-677-19; 47335-677-13; 47335-677-18; 47335-678-83; 47335-678-81; 47335-678-19; 47335-678-13; 47335-678-18; 47335-679-83; 47335-679-81; 47335-679-19; 47335-679-13; 47335-679-18 | Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory. | SUN PHARMACEUTICAL INDUSTRIES INC / Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles | Class II | Terminated |
| D-0178-2023 | 01-12-2023 | Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3. Package NDCs: 0487-6105-01 | CGMP Deviations: potential for trace amounts of product carryover. | Nephron Sc Inc / 389,730 vials | Class II | Terminated |
| D-0168-2023 | 01-12-2023 | Allopurinol Tablets USP, 100 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 16729-134-01 Package NDCs: 16729-134-10; 16729-134-01; 16729-134-16; 16729-134-17; 16729-135-10; 16729-135-01; 16729-135-16; 16729-135-17 | Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. | Accord Healthcare, Inc. / 87,576 bottles | Class II | Terminated |
| D-0177-2023 | 01-12-2023 | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3. Package NDCs: 0487-4301-25; 0487-4301-10; 0487-4301-05; 0487-4301-50 | CGMP Deviations: potential for trace amounts of product carryover. | Nephron Sc Inc / 378 bags | Class II | Terminated |
| D-0269-2023 | 01-11-2023 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories Package NDCs: 68001-500-00; 68001-500-03; 68001-500-08; 68001-501-00; 68001-501-03; 68001-501-08; 68001-502-00; 68001-502-03; 68001-502-08; 68001-503-00 | Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories. | Amerisource Health Services LLC / (a) 6670 100-count (b) 2666 500-count bottles | Class II | Terminated |
| D-0326-2023 | 01-10-2023 | Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Consolidated Chemical, Inc / 3186 bottles | Class II | Ongoing |
| D-0325-2023 | 01-10-2023 | Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02 | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Consolidated Chemical, Inc / 4 oz: 6580 bottles; 8 oz: 1248 bottles | Class II | Ongoing |
| D-0099-2023 | 01-06-2023 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 38,830 syringes | Class II | Terminated |
| D-0170-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 6,336 bottles | Class II | Terminated |
| D-0171-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 2628 bottles | Class II | Terminated |
| D-0169-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 49,632 bottles | Class II | Terminated |
| D-0162-2023 | 01-05-2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08 | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. | MACLEODS PHARMA USA, INC / 10052 bottles | Class III | Terminated |
| D-0167-2023 | 01-04-2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. Package NDCs: 10599-003-01 | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months. | Intersect ENT, Inc. / 9898 pouches | Class III | Terminated |
| D-0119-2023 | 12-30-2022 | Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0108-2023 | 12-30-2022 | QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 6 vials | Class II | Terminated |
| D-0124-2023 | 12-30-2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0120-2023 | 12-30-2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0106-2023 | 12-30-2022 | TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 750 vials | Class II | Terminated |
| D-0113-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0118-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 8 vials | Class II | Terminated |
| D-0107-2023 | 12-30-2022 | QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 39 vials | Class II | Terminated |
| D-0104-2023 | 12-30-2022 | QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 12 vials | Class II | Terminated |
| D-0115-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0117-2023 | 12-30-2022 | TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 525 vials | Class II | Terminated |
| D-0116-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0111-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 108 vials | Class II | Terminated |
| D-0105-2023 | 12-30-2022 | QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 56 vials | Class II | Terminated |
| D-0110-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0112-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0114-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0122-2023 | 12-30-2022 | BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0125-2023 | 12-30-2022 | BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 1200 vials | Class II | Terminated |
| D-0102-2023 | 12-30-2022 | Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0123-2023 | 12-30-2022 | TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 36 vials | Class II | Terminated |
| D-0121-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 8 vials | Class II | Terminated |
| D-0109-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
