Why it was recalled
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Product description
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Lot numbers, UPCs & expiration codes
Lot # 089A016, Exp 12/2020
Where it was sold
U.S.A. Nationwide
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-1368-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 15, 2019
- FDA report date
- Jul 1, 2020
- Quantity
- 15,072 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1368-2020, exactly as published.
Show all FDA fields
- City
- Saddle Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85829
- Address
- 250 Pehle Ave Ste 601
- Code information
- Lot # 089A016, Exp 12/2020
- Postal code
- 07663-5832
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1368-2020
- Classification
- Class III
- Recalling firm
- Rising Pharmaceuticals, Inc.
- Product quantity
- 15,072 bottles
- Termination date
- Aug 22, 2022
- Reason for recall
- Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Nov 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2020