Unrated Drug recall · FDA · Published May 1, 2023

RemedyRepack Ketotifen Eye Drops Recall: CGMP Deviations Risk

RemedyRepack Inc. recalls Ketotifen Fumarate 0.025% eye drops due to quality program discontinuation. Affected units may not meet safety standards. Consumers should check NDC and lot numbers for recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0577-2023Drug RemedyRepack ›

Recall notice

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.

Take action

Contact the company

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571

✎ GovInfoNow plain-language explainer

RemedyRepack Inc. is recalling Ketotifen Fumarate 0.025% eye drops because the manufacturer discontinued their quality assurance program. This could mean the product doesn't meet safety standards, but the recall doesn't specify immediate harm risks. Read more at govinfonow.com/recall/33519-remedyrepack-ketotifen-eye-drops-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33519-remedyrepack-ketotifen-eye-drops-recall-cgmp-deviations-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0577-2023

Cite this page

“RemedyRepack Ketotifen Eye Drops Recall: CGMP Deviations Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33519-remedyrepack-ketotifen-eye-drops-recall-cgmp-deviations-risk. Based on FDA recall #D-0577-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0577-2023%22&limit=1).

The FDA announced on May 1, 2023, that RemedyRepack Inc. is recalling Ketotifen Fumarate antihistamine eye drops due to CGMP deviations. The recall affects specific lots distributed to three direct accounts in Pennsylvania.

How to tell if you have it

Brand: RemedyRepack
Product: Ketotifen Fumarate 0.025%, Antihistamine eye drops, 5mL bottle
NDC: 70518-1142-00; Source NDC # 17477-0717-10
Lot codes: B1643789-041022 (EXP 03/31/2024), B1894150-100722, B1891573-100622 (EXP. 7/31/2024)
Manufacturer: Akorn, Lake Forrest IL 60045
Repackager: RemedyRepack Inc., Indiana, PA 15701
Quantity: 12 5mL bottles
Distribution: Three direct accounts in PA

The hazard

According to the FDA, the hazard involves CGMP deviations resulting from the discontinuation of the manufacturer's quality program. This failure would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since 2015-02-18. Recent brand recalls include Clindamycin Capsules recalled on 2025-04-22 and 2025-03-24 due to CGMP deviations, as well as Carvedilol Tablets recalled on 2025-01-24 for N-Nitroso Impurity Risk. Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (2026-04-01), Wells Pharma Fentanyl Citrate Recall (2026-04-01), and Blossom Pharmaceuticals Globe Clotrimazole Cream Recall (2025-10-31).

How to tell if you have this one

Check for the NDC number 70518-1142-00 and lot numbers B1643789-041022 (expiring 03/31/2024) or B1894150-100722/B1891573-100622 (expiring 07/31/2024). The product was repackaged by RemedyRepack Inc. in Indiana, PA.

Brand
RemedyRepack
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Distribution
Product was distrituded to three direct account in PA.

Recall number	Product, codes & lots	Quantity
D-0576-2023	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; Lot # B2169656-032223, B2169663-032223, B2169680-032223, B2169713-032223, B2109085-021423, B2109094-021423, B2049229-010623, B2049235-010623, Exp. Date 04/30/2025; B2049224-010623, B2027905-122222, B2027920-122222, B2027941-122222, B2027968-122222, B2027979-122222, B2027989-122222, B2005343-120922, B2005333-120922, Exp. Date 03/31/2025; B1970782-112122, Exp. Date 01/31/2025; B1878510-092922, Exp. Date 11/30/2024; B1904609-101322, B1866210-092222, Exp. Date 12/31/2024; B1711316-060222, B1711328-060222, Exp. Date 09/30/2024; B1660244-042522, Exp. Date 07/31/2024; B1660288-042522, B1617673-032422, Exp. Date 06/30/2024; B1617737-032422, B1617744-032422, B1563407-021422, B1563498-021422, Exp. Date 05/31/2024; B1539158-012822, B1518050-011222, B1498175-122921, Exp. Date 04/30/2024; B1498194-122921, B1455889-112621, B1455918-112621, Exp. Date 03/31/2024; B1455901-112621, B1396346-101421, B1383216-100721, Exp. Date 01/31/2024; B1383214-100721, B1353451-091721, B1353463-091721, B1353480-091721, B1274069-071521, B1274079-071521, B1274052-071521, B1234313-061721, B1234339-061721, B1203592-052721, B1203608-052721, B1163740-042921, Exp. Date 09/30/2023; B1163745-042921, B1163747-042921, B1140139-040821, Exp. Date 05/31/2023.	9,038 vials
D-0577-2023	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;; Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024	12 5mL bottles
D-0578-2023	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; Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;	29 x 30-count card, 1 x 100 UD box

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the NDC number 70518-1142-00 and lot numbers listed in the recall notice to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed in Pennsylvania.

FDA distribution: “Product was distrituded to three direct account in PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Pennsylvania.

Recall timeline

FDA published this recall 23 days after the firm started it.

May 1, 2023Firm started the recall
May 16, 2023FDA classified it Class II
May 24, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/33519-remedyrepack-ketotifen-eye-drops-recall-cgmp-deviations-risk">RemedyRepack Ketotifen Eye Drops Recall: CGMP Deviations Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0577-2023 (May 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0577-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.