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RACEPINEPHRINE HYDROCHLORIDE Recall D-1325-2022

Description: Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

RACEPINEPHRINE HYDROCHLORIDE Recall D-1325-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1325-2022
Event ID90553
BrandS2
Generic NameRACEPINEPHRINE HYDROCHLORIDE
ManufacturerRACEPINEPHRINE HYDROCHLORIDE
Original Package?1
Active SubstanceRACEPINEPHRINE HYDROCHLORIDE
Drug RouteRESPIRATORY (INHALATION)
DistributionNationwide in the USA.
Quantity23 cartons
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0487-5901
Drug UPC0304875901999
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)b8a789aa-55e6-6497-e053-2a95a90a4169
Structured Product Labeling (SPL Set ID)dd1b35c7-b23b-4b95-8162-df3d263fe32e
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