Ophthalmic solution recalled for defective container with lodged spike
FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.
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 for a defective container on an ophthalmic product with risk of eye injury; no reported illnesses or injuries, meeting the High-severity threshold for risk-of-harm products without actual harm reported.
Plain-English summary
FDC Limited is recalling Timolol Maleate Ophthalmic Solution USP 0.5% distributed by Rising Pharmaceuticals Inc. The recall encompasses 362,544 bottles (5mL size) distributed nationwide in the United States.
The defect involves a yellow spike from the bottle cap that has lodged in the application nozzle. This could pose a risk of eye injury if the spike contacts the eye during normal use of the eye drops.
The affected lots are: Lot 083J022 (expiration date September 25), Lot 083L046 (expiration date November 25), and Lot 083H009 (expiration date July 25).
Patients should stop using affected bottles immediately and consult their pharmacist or healthcare provider for guidance on obtaining replacement medication. Any adverse effects should be reported.
The recalled product
- Product
- TIMOLOL MALEATE (TIMOLOL MALEATE)
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Category
- Drug — Ophthalmic Solution
- Hazard
- container-defect
- eye-injury-risk
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 (6)
- Lot Number: 083J022
- Expiration Date: September- 25
- 083L046
- Expiration date: November- 25
- 083H009
- Expiration date: July- 25
UPCs (2)
- 0364980513050
- 0364980514057
Distribution
Distributed nationwide across the United States.
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