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OLOPATADINE HYDROCHLORIDE Recall D-1321-2022

Description: Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.

OLOPATADINE HYDROCHLORIDE Recall D-1321-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1321-2022
Event ID90553
BrandPATADAY ONCE DAILY RELIEF
Generic NameOLOPATADINE HYDROCHLORIDE
ManufacturerOLOPATADINE HYDROCHLORIDE
Original Package?1
Active SubstanceOLOPATADINE HYDROCHLORIDE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity1 box
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0065-8150
Recall Initiation Date20220629
Report Date20220817
Classification Date20220805
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier2XG66W44KF
Drug Application NumberNDA021545
Structured Product Labeling (SPL ID)37f1bf3b-3e04-42b3-aa80-a22afd9b3e55
Structured Product Labeling (SPL Set ID)1c7d2342-ba1c-4244-9814-d92a05725d4e
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