Why it was recalled
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].
Lot numbers, UPCs & expiration codes
Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0632-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 18, 2024
- FDA report date
- Aug 21, 2024
- Quantity
- 362,544 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0632-2024, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 94990
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
- Report date
- Aug 21, 2024
- Product type
- Drugs
- Recall number
- D-0632-2024
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 362,544 bottles
- Reason for recall
- Defective container; yellow colored spike from cap lodged in the nozzle
- Voluntary / mandated
- Voluntary: Firm initiated
- 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].
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jul 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2024