Drug Enforcement D-0093-2023

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.

Status

Completed

Classification

Class III

Report Date

January 4, 2023

Termination Date

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Product Information

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
Product quantity
22,027 bottles
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Apotex Corp.
Address
2400 N Commerce Pkwy Ste 400

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0093-2023
Event ID
91353
Recall initiation date
December 21, 2022
Center classification date
December 28, 2022
Code info
Lot# TA4844, Exp 03/2023
More code info
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