FDAFDA · Food and drugs·Recall number D-1367-2020
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05
Published July 1, 2020 · Recall initiated: November 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIMOLOL MALEATE
- Manufacturer
- Rising Pharmaceuticals, Inc.
- Distributor
- U.S.A. Nationwide
- UPC
- 0364980513050
- Lot
- Lot # 089A016, Exp 12/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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