Accord Healthcare, Inc. recalls
31 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Accord Healthcare, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx…
Subpotent drug: out of specification results
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord…
Presence of Particulate Matter: Particulate matter identified as fiber.
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose…
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord…
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for:…
CGMP Deviations: recalling drug products following an FDA inspection.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord…
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord…
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for:…
CGMP Deviations: recalling drug products following an FDA inspection.
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials…
CGMP Deviations: recalling drug products following an FDA inspection.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10,…
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15,…
CGMP Deviations: recalling drug products following an FDA inspection.
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty…
CGMP Deviations: recalling drug products following an FDA inspection.
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for:…
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3…
CGMP Deviations: recalling drug products following an FDA inspection.
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01…
CGMP Deviations: recalling drug products following an FDA inspection.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC…
CGMP Deviations: recalling drug products following an FDA inspection.
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial,…
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord…
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for:…
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord…
CGMP Deviations: recalling drug products following an FDA inspection.
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord…
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for:…
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial