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RemedyRePack Inc.

5 ongoing recalls and 56 historical records

Based on the official records currently available to Public Health Trace, 5 recalls naming RemedyRePack Inc. are currently shown as ongoing. The other 56 records below are historical.

Public Health Trace has 61 recalls naming RemedyRePack Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 61 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20159
20172
20189
20192
20205
20211
20228
202318
20243
20254
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FDA Recall OngoingHistorical recordClass II

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

by RemedyRePack Inc.

Reason
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Published
May 14, 2025
Distribution
Within U.S - PA, VA, FL.

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FDA Recall OngoingHistorical recordClass II

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

by RemedyRePack Inc.

Reason
CGMP Deviations
Published
April 30, 2025
Distribution
PA

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FDA Recall TerminatedTerminated: July 17, 2025Historical recordClass II

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

by RemedyRePack Inc.

Reason
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Published
February 12, 2025
Distribution
FL

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FDA Recall OngoingHistorical recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

by RemedyRePack Inc.

Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Published
January 1, 2025
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 31, 2025Historical recordClass II

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

by RemedyRePack Inc.

Reason
CGMP Deviations: Out of specification for dissolution
Published
July 24, 2024
Distribution
Nationwide

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FDA Recall TerminatedTerminated: July 1, 2024Historical recordClass II

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

by RemedyRePack Inc.

Reason
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Published
June 19, 2024
Distribution
Product was distributed to one medical f…

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FDA Recall TerminatedTerminated: September 9, 2024Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 24, 2023
Distribution
Product was distrituded to three direct…

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FDA Recall OngoingHistorical recordClass II

Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 24, 2023
Distribution
Product was distrituded to three direct…

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FDA Recall TerminatedTerminated: June 21, 2023Historical recordClass II

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

by RemedyRePack Inc.

Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 24, 2023
Distribution
Product was distrituded to three direct…

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FDA Recall TerminatedTerminated: October 19, 2023Historical recordClass II

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

by RemedyRePack Inc.

Reason
cGMP Deviations
Published
April 12, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 19, 2023Historical recordClass II

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Published
April 12, 2023
Distribution
Nationwide

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Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name RemedyRePack Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

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