RemedyRepack Inc.

FDA Regulatory Profile

Summary

Total Recalls
61 (1 Class I)
510(k) Clearances
0
Inspections
5
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0411-2025Class IIClindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack IApril 22, 2025
D-0378-2025Class IIClindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack IMarch 24, 2025
D-0217-2025Class IICarvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: GJanuary 24, 2025
D-0165-2025Class IIDuloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 couDecember 2, 2024
D-0611-2024Class IIPotassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only,June 26, 2024
D-0549-2024Class IIPhenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., IndMay 31, 2024
D-0489-2024Class IITraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blMay 2, 2024
D-0577-2023Class IIKetotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, May 1, 2023
D-0578-2023Class IIPyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UDMay 1, 2023
D-0576-2023Class IILORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, RMay 1, 2023
D-0494-2023Class IIRopinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., March 20, 2023
D-0492-2023Class IIDoxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 7March 20, 2023
D-0502-2023Class IIRosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottMarch 20, 2023
D-0493-2023Class IIGlimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (March 20, 2023
D-0495-2023Class IIRosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 1March 20, 2023
D-0499-2023Class IIRopinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., InMarch 20, 2023
D-0497-2023Class IITadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 157March 20, 2023
D-0491-2023Class IIAtorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottMarch 20, 2023
D-0503-2023Class IISimvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottlMarch 20, 2023
D-0498-2023Class IIAtorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottlMarch 20, 2023