TRAVOPROST Recall D-0748-2022
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.
TRAVOPROST Recall D-0748-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0748-2022 |
| Event ID | 89906 |
| Brand | TRAVOPROST OPHTHALMIC SOLUTION, 0.004% |
| Generic Name | TRAVOPROST OPHTHALMIC SOLUTION, 0.004% |
| Manufacturer | TRAVOPROST OPHTHALMIC SOLUTION, 0.004% |
| Original Package? | 1 |
| Active Substance | TRAVOPROST |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 20,112 bottles |
| Recall Reason | 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. |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 0378-9651 |
| Product NUI | N0000175454 M0017805 |
| Drug UPC | 0303789651327 0303789651501 |
| Pharma Class (EPC) | Prostaglandin Analog [EPC] |
| Pharma Class (CS) | Prostaglandins [CS] |
| Recall Initiation Date | 20220401 |
| Report Date | 20220413 |
| Classification Date | 20220406 |
| Address | 3711 Collins Ferry Rd Morgantown, WV 26505-2362 United States |
| Recalling Firm | Mylan Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WJ68R08KX9 |
| Drug Application Number | ANDA205050 |
| Structured Product Labeling (SPL ID) | f359e919-2ec2-408b-b14c-c08ce069e05a |
| Structured Product Labeling (SPL Set ID) | 00dc284f-fd96-423b-bb8f-b90ee13439bf |
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