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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 801–820 of 1,000 recalls

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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.

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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.

Accord Healthcare, Inc.

CGMP Deviations: recalling drug products following an FDA inspection.

February 7, 2023 · DrugView details →

Class IITerminated

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.

Alvogen, Inc

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

February 6, 2023 · DrugView details →

Class IITerminated

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

Leadiant Biosciences, Inc.

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

February 3, 2023 · DrugView details →

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