Accord Healthcare, Inc.

FDA Regulatory Profile

Summary

Total Recalls
93 (2 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

accord healthcare, accord healthcare, inc

Recent Recalls

NumberClassProductDate
D-0006-2026Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured fSeptember 16, 2025
D-0520-2025Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: AccJune 20, 2025
D-0521-2025Class IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: AJune 20, 2025
D-0519-2025Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: June 20, 2025
D-0518-2025Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: AcJune 20, 2025
D-0523-2025Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: June 20, 2025
D-0522-2025Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for:June 20, 2025
D-0524-2025Class IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for:June 20, 2025
D-0396-2025Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for AccordApril 10, 2025
D-0397-2025Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord April 10, 2025
D-0395-2025Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord April 10, 2025
D-0394-2025Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for AccordApril 10, 2025
D-0076-2025Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: November 8, 2024
D-0032-2025Class IICinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bOctober 10, 2024
D-0031-2025Class IICinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bOctober 10, 2024
D-0030-2025Class IICinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per boOctober 10, 2024
D-0010-2025Class IICisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, October 1, 2024
D-0580-2024Class IIIDodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, ManufJune 18, 2024
D-0918-2023Class IIBivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord HealthcareJuly 3, 2023
D-0917-2023Class IIAtropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only,July 3, 2023