Ketotifen Fumarate eye drops recalled due to manufacturing quality control deviations
RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting a direct-contact product (eye drops) due to quality control deviations. While no illnesses or injuries have been reported, the discontinuation of the manufacturer's quality assurance program presents a potential risk to product identity, strength, and purity.
Plain-English summary
RemedyRepack Inc. is recalling Ketotifen Fumarate 0.025% antihistamine eye drops, 5mL bottles (NDC 70518-1142-00), repackaged from Akorn's original formulation (source NDC 17477-0717-10, manufactured in Lake Forest, Illinois).
The recall was issued because the drug manufacturer discontinued its quality assurance program, raising concerns about whether the product meets the identity, strength, quality, and purity specifications required under FDA good manufacturing practice (CGMP) regulations. As a result, the product may not possess the therapeutic characteristics claimed on the label.
The affected products were distributed to three direct accounts in Pennsylvania. Affected lot numbers are B1643789-041022 (expiration 03/31/2024), B1894150-100722, and B1891573-100622 (expiration 7/31/2024). Each shipment contained 12 5mL bottles.
Patients and healthcare providers should discontinue use of affected product and consult with their healthcare provider or pharmacist regarding alternative treatments. Return the product to the dispensing pharmacy.
The recalled product
- Product
- 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;
- Manufacturer
- RemedyRepack Inc.
- Hazard
- quality-control-failure
- cgmp-deviation
- purity-concern
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # B1643789-041022
- EXP 03/31/2024
- B1894150-100722
- B1891573-100622
- EXP. 7/31/2024
Distribution
Distributed in 1 state:
- PA
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