Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2024-08-21
Distribution
Nationwide in the US
Product quantity
362,544 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container; yellow colored spike from cap lodged in the nozzle
Product description
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].
Code / lot info
Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.