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ATROPINE SULFATE Recall D-1035-2022

Description: Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

ATROPINE SULFATE Recall D-1035-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1035-2022
Event ID89646
BrandISOPTO ATROPINE
Generic NameATROPINE SULFATE
ManufacturerATROPINE SULFATE
Original Package?1
Active SubstanceATROPINE SULFATE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity13 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0065-0303
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 Identifier03J5ZE7KA5
Drug Application NumberNDA208151
Structured Product Labeling (SPL ID)a834cece-0e6c-4fc4-af6d-4aa8827d5cc1
Structured Product Labeling (SPL Set ID)20491566-e6eb-8d4a-3083-77ea429f7bc4
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