Home / Recalls / RemedyRepack Inc. / D-0490-2023

D-0490-2023 Class II Terminated

Recalled by RemedyRepack Inc. — Indiana, PA

Recall Details

Product Type
Drugs
Report Date
April 12, 2023
Initiation Date
March 20, 2023
Termination Date
October 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 bottles

Product Description

Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

Reason for Recall

cGMP Deviations

Distribution Pattern

RemedyRepack distributed product to consignees nationwide within the United States

Code Information

Lot #: J0620431-052322, Exp. Date 05/31/23

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  • D-0217-2025 Class II — Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards) (January 24, 2025)
  • D-0165-2025 Class II — Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518 (December 2, 2024)
  • D-0611-2024 Class II — Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count bl (June 26, 2024)
  • D-0549-2024 Class II — Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: Rem (May 31, 2024)
  • D-0489-2024 Class II — TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824 (May 2, 2024)
  • D-0577-2023 Class II — Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lak (May 1, 2023)
  • D-0578-2023 Class II — Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534 (May 1, 2023)
  • D-0576-2023 Class II — LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lak (May 1, 2023)