Product Safety Recalls

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APRACLONIDINE HYDROCHLORIDE Recall D-1026-2022

Description: Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05

APRACLONIDINE HYDROCHLORIDE Recall D-1026-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1026-2022
Event ID89646
BrandAPRACLONIDINE
Generic NameAPRACLONIDINE
ManufacturerAPRACLONIDINE
Original Package?1
Active SubstanceAPRACLONIDINE HYDROCHLORIDE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity21 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC61314-665
Drug UPC0361314665058
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 IdentifierD2VW67N38H
Drug Application NumberNDA020258
Structured Product Labeling (SPL ID)e67e69ac-f1e7-4e41-b7a3-63a14da106da
Structured Product Labeling (SPL Set ID)04ad82af-e7ba-4f40-a120-be9d33cf0c7b
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