March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,00
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls 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-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,0
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b)
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healt
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcar
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare,
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for:
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured fo
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-cou
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-cou
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls 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
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls 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-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls 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-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls 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-cou
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pha
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b)
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.