FDAFDA · Food and drugs·Recall number D-0632-2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
Published August 21, 2024 · Recall initiated: July 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container; yellow colored spike from cap lodged in the nozzle
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Distributor
- Nationwide in the US
- UPC
- 0364980513050
- Lot
- Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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