Timolol Maleate Ophthalmic Solution recalled for failed stability specifications
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a stability failure in a pharmaceutical product. No illnesses or injuries have been reported. The defect is a quality and manufacturing issue affecting drug potency rather than an acute safety hazard, consistent with the rubric criterion that FDA Class III recalls typically score 1 or 2.
Plain-English summary
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL bottles (NDC 60505-1005-4) for failed stability specifications. The recall affects lot TA4844 (expiration date 03/2023) and applies to approximately 22,027 bottles distributed nationwide in the USA.
The affected drug failed stability testing requirements. During stability testing, the product exhibited weight loss at the 18-month timepoint that exceeded acceptable specifications. The product is projected to lose 21.1% of its weight by the end of shelf life. This weight loss may result in changes to drug concentration and effectiveness.
Patients and healthcare providers should discontinue use of affected bottles and contact Apotex Corp. for return or disposal instructions. Patients should consult their healthcare provider about continued treatment options to ensure no gap in medication coverage.
The recalled product
- Product
- Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 22,027
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 (2)
- Lot# TA4844
- Exp 03/2023
Distribution
Distributed nationwide across the United States.
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