Recalls / Class II
Class IID-0748-2022
Product
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
- Brand name
- Travoprost Ophthalmic Solution, 0.004%
- Generic name
- Travoprost Ophthalmic Solution, 0.004%
- Active ingredient
- Travoprost
- Route
- Ophthalmic
- NDC
- 0378-9651
- FDA application
- ANDA205050
- Affected lot / code info
- Lot # TV11W101, Exp Mar 2023
Why it was recalled
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3711 Collins Ferry Rd, Morgantown, West Virginia 26505-2362
Distribution
- Quantity
- 20,112 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-04-01
- FDA classified
- 2022-04-06
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0748-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.