Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0748-2022
Event ID89906
BrandTRAVOPROST OPHTHALMIC SOLUTION, 0.004%
Generic NameTRAVOPROST OPHTHALMIC SOLUTION, 0.004%
ManufacturerTRAVOPROST OPHTHALMIC SOLUTION, 0.004%
Original Package?1
Active SubstanceTRAVOPROST
Drug RouteOPHTHALMIC
DistributionNationwide in the USA and Puerto Rico
Quantity20,112 bottles
Recall ReasonSubpotent 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 ClassificationClass II
Drug Code Info20220413
Product NDC0378-9651
Product NUIN0000175454 M0017805
Drug UPC0303789651327 0303789651501
Pharma Class (EPC)Prostaglandin Analog [EPC]
Pharma Class (CS)Prostaglandins [CS]
Recall Initiation Date20220401
Report Date20220413
Classification Date20220406
Address3711 Collins Ferry Rd
Morgantown, WV 26505-2362
United States
Recalling FirmMylan Pharmaceuticals Inc
Initial Notification Letter
Unique Ingredient IdentifierWJ68R08KX9
Drug Application NumberANDA205050
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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