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Recall Observatory FDA recall evidence

Drug product

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].

D-0632-2024

July 18, 2024

Class II

Product summary

Firm
FDC Limited
Event
Event 94990
Status
Ongoing
Classification
Class II
Quantity
362,544 bottles
Official record key
drug-enforcement:D-0632-2024

Official wording

Reason: Defective container; yellow colored spike from cap lodged in the nozzle

Code information: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25

Distribution pattern: Nationwide in the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container; yellow colored spike from cap lodged in the nozzle