Product Safety Recalls

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ZIPRASIDONE HYDROCHLORIDE Recall D-1112-2022

Description: Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial, Rx only, MFG: Viatris, NDC 0049-3920-83

ZIPRASIDONE HYDROCHLORIDE Recall D-1112-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1112-2022
Event ID89646
BrandGEODON
Generic NameZIPRASIDONE HYDROCHLORIDE
ManufacturerZIPRASIDONE HYDROCHLORIDE
Original Package?1
Active SubstanceZIPRASIDONE HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 carton/10 vials
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0049-0052 0049-3960 0049-3980
Product NUIN0000175430
Drug UPC0300493990605 0300490052603 0300493980606
Pharma Class (EPC)Atypical Antipsychotic [EPC]
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 Identifier216X081ORU 6UKA5VEJ6X
Drug Application NumberNDA020825
Structured Product Labeling (SPL ID)234488e0-550f-4c40-bd70-d98d051371b9
Structured Product Labeling (SPL Set ID)8326928a-2cb6-4f7f-9712-03a425a14c37
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