Recalls / Class III
Class IIID-1367-2020
Product
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05
- Brand name
- Timolol Maleate
- Generic name
- Timolol Maleate
- Active ingredient
- Timolol Maleate
- Route
- Ophthalmic
- NDCs
- 64980-513, 64980-514
- FDA application
- ANDA077259
- Affected lot / code info
- Lot # 089A016, Exp 12/31/2020
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.
Recalling firm
- Firm
- Rising Pharmaceuticals, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 250 Pehle Ave Ste 601, N/A, Saddle Brook, New Jersey 07663-5832
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-11-15
- FDA classified
- 2020-06-29
- Posted by FDA
- 2020-07-01
- Terminated
- 2022-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1367-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.