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.
Product description
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Lot numbers, UPCs & expiration codes
Lot # TV11W101, Exp Mar 2023
Where it was sold
Nationwide in the USA and Puerto Rico
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-0748-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 20,112 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0748-2022, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 89906
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot # TV11W101, Exp Mar 2023
- Postal code
- 26505-2362
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0748-2022
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 20,112 bottles
- Termination date
- Feb 27, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 1, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2022