Home / Recalls / RemedyRepack Inc. / D-0611-2024

D-0611-2024 Class II Terminated

Recalled by RemedyRepack Inc. — Indiana, PA

Recall Details

Product Type: Drugs
Report Date: July 24, 2024
Initiation Date: June 26, 2024
Termination Date: January 31, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 142 blister cards, 30 per blister card

Product Description

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03

Reason for Recall

CGMP Deviations: Out of specification for dissolution

Distribution Pattern

USA Nationwide

Code Information

Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025

Other recalls by RemedyRepack Inc.

D-0411-2025 Class II — Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackage (April 22, 2025)
D-0378-2025 Class II — Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackage (March 24, 2025)
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-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)
D-0502-2023 Class II — Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), (March 20, 2023)