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RACEPINEPHRINE HYDROCHLORIDE Recall D-1324-2022

Description: Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.

RACEPINEPHRINE HYDROCHLORIDE Recall D-1324-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1324-2022
Event ID90553
BrandASTHMANEFRIN
Generic NameRACEPINEPHRINE HYDROCHLORIDE
ManufacturerRACEPINEPHRINE HYDROCHLORIDE
Original Package?1
Active SubstanceRACEPINEPHRINE HYDROCHLORIDE
Drug RouteRESPIRATORY (INHALATION)
DistributionNationwide in the USA.
Quantity1 box
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0487-2784
Drug UPC0304872784014
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 Identifier336096P2WE
Drug Application Numberpart341
Structured Product Labeling (SPL ID)b8a6aed9-a173-f172-e053-2995a90a17a0
Structured Product Labeling (SPL Set ID)80480838-832c-4fdd-9f8e-f6f877ae3549
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