All Recalls

95,094 total recalls in our database

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.

Nephron Sterile Compounding Center

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility

Feb 22, 2023 Prescription Drugs Nationwide View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.

Nephron Sterile Compounding Center

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility

Feb 22, 2023 Prescription Drugs Nationwide View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

DuPont Nutrition USA

💊 Drugs Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Feb 1, 2023 Other Drugs Nationwide View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

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.

Accord Healthcare

💊 Drugs Class I - Dangerous

CGMP Deviations: recalling drug products following an FDA inspection.

Feb 7, 2023 Prescription Drugs View Details →

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.

Nephron Sterile Compounding Center

💊 Drugs Class I - Dangerous

Lack of Assurance of Sterility

Feb 22, 2023 Prescription Drugs Nationwide View Details →

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

DuPont Nutrition USA

💊 Drugs Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Feb 1, 2023 Other Drugs Nationwide View Details →