FDA recall D-0093-2023

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

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.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-12-21

Report date

2023-01-04

Termination date

2025-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2023