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PREDNISOLONE ACETATE Recall D-1105-2022

Description: Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05

PREDNISOLONE ACETATE Recall D-1105-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1105-2022
Event ID89646
BrandPREDNISOLONE ACETATE
Generic NamePREDNISOLONE ACETATE
ManufacturerPREDNISOLONE ACETATE
Original Package?1
Active SubstancePREDNISOLONE ACETATE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity50 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC61314-637
Drug UPC0361314637055
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier8B2807733D
Drug Application NumberNDA017469
Structured Product Labeling (SPL ID)09d17d81-3127-46b9-8553-ffc22e9434a8
Structured Product Labeling (SPL Set ID)05d205c7-8f51-46b9-a6c5-4199bc432b26
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