Mylan Pharmaceuticals Inc: Drug Recall
Recall #D-0748-2022 · 04/01/2022
Class II: Risk
Recall Details
- Recall Number
- D-0748-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Mylan Pharmaceuticals Inc
- Status
- Terminated
- Date Initiated
- 04/01/2022
- Location
- Morgantown, WV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,112 bottles
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.
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
Other Recalls by Mylan Pharmaceuticals Inc
- Class II: Risk 02/25/2025
- Class I: Dangerous 07/05/2022
- Class I: Dangerous 04/12/2022
- Class II: Risk 04/07/2022
- Class II: Risk 01/21/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.