Drug FDA Class II Ongoing Foreign material
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].
FDC Limited Published Aug 21, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact FDC Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Defective container; yellow colored spike from cap lodged in the nozzle
Hazards
Yellow plastic spike from cap · primary
Affected products (1)
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].
TIMOLOL MALEATE · 362,544 bottles
NDC: 64980-513, 64980-514, 64980-513-05, 64980-513-01, 64980-513-15, 64980-514-05, 64980-514-01, 64980-514-15
Lot codes: Number
Code info: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Affected areas
Nationwide
Timeline
- InitiatedJul 18, 2024
- PublishedAug 21, 2024
- Recall number
- D-0632-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.