Drug recall D-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.
Reason for recall
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.
Lots and codes
Lot # TV11W101, Exp Mar 2023
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Quantity
- 20,112 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 1, 2022
- Terminated
- February 27, 2023
Related products
- Travoprost Ophthalmic Solution, 0.004% – drug information
- NDC 0378-9651 Travoprost Ophthalmic Solution, 0.004% · Travoprost .04 mg/mL · Mylan Pharmaceuticals Inc.