CLASS II ONGOING Drug recall · Reported 24 May 2023 · FDA Enforcement Report

Ketotifen Fumarate 0.025 %, Antihistamine eye drops, MFG recalled

RemedyRepack is recalling Ketotifen Fumarate 0.025 %, Antihistamine eye drops, MFG: Akorn, Lake Forrest IL 60045, distributed in Pennsylvania. The recall was initiated on 1 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024

Quantity recalled12 5mL bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0577-2023
FDA event ID: 92239
Recalling firm: RemedyRepack, Indiana, PA
Classification: Class II
Status: Ongoing
Recall initiated: 1 May 2023
FDA classified: 16 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Eye Drops

Timeline

1 May 2023	Recall initiated by company
16 May 2023	Classified by FDA	+15 days
24 May 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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;

Where it was distributed

Product was distrituded to three direct account in PA.

Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024

Where was it sold?

Product was distrituded to three direct account in PA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 92239

Reported	Class	Recall	Company	Reason	Where
24 May 2023	CLASS II	Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card recalled	RemedyRepack	Manufacturing (CGMP) Deviations	PA
24 May 2023	CLASS II	LORazepam Injection, 2mg / mL Single Dose vial recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	PA

More recalls from RemedyRepack

All 61

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack	RemedyRePack	Manufacturing (CGMP) Deviations	FL, PA, VA
30 Apr 2025Drug	CLASS II	Clindamycin HCl, QTY recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	PA
12 Feb 2025Drug	CLASS II	Carvedilol, QTY: per Blister Pack ( blister cards) recalled	RemedyRepack	Nitrosamine Impurity	FL
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled	RemedyRepack	Nitrosamine Impurity	Nationwide
24 Jul 2024Drug	CLASS II	Potassium Chloride Micro 10mEq recalled by RemedyRepack	RemedyRepack	Potency & Assay	Nationwide

Other Ketotifen recalls

All 2

Reported	Class	Recall	Company	Reason	Where
17 Aug 2022Drug	CLASS II	Systane Zaditor, ketotifen fumarate ophthalmic solution recalledZaditor	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide