D-0748-2022 Class II Terminated
FDA drug recall D-0748-2022 was initiated by Mylan Pharmaceuticals Inc on Apr 1, 2022 and is designated Class II. 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… The recall status is terminated (terminated Feb 27, 2023). Affected quantity: 20,112 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 13, 2022
- Initiation Date
- Apr 1, 2022
- Termination Date
- Feb 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,112 bottles
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.
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.
Distribution pattern
Nationwide in the USA and Puerto Rico
Code information
Lot # TV11W101, Exp Mar 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0748-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026