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AZITHROMYCIN MONOHYDRATE Recall D-0997-2022

Description: Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10

AZITHROMYCIN MONOHYDRATE Recall D-0997-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0997-2022
Event ID89646
BrandAZITHROMYCIN
Generic NameAZITHROMYCIN
ManufacturerAZITHROMYCIN
Original Package?1
Active SubstanceAZITHROMYCIN MONOHYDRATE
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity13 carton/10 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC55150-174
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 IdentifierJTE4MNN1MD
Drug Application NumberANDA203294
Structured Product Labeling (SPL ID)87cd6c86-6488-441b-aa9c-5811fbc5771e
Structured Product Labeling (SPL Set ID)7b81436e-d14a-4353-a22d-253f45e2e576
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