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Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Onta...

FDA Recall #D-0093-2023 — Class III — December 21, 2022

Recall #D-0093-2023 Date: December 21, 2022 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

Recalling Firm

Apotex Corp. — Weston, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

22,027 bottles

Distribution

USA Nationwide

Code Information

Lot# TA4844, Exp 03/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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