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CIPROFLOXACIN HYDROCHLORIDE Recall D-1044-2022

Description: Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05

CIPROFLOXACIN HYDROCHLORIDE Recall D-1044-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1044-2022
Event ID89646
BrandCIPROFLOXACIN HYDROCHLORIDE
Generic NameCIPROFLOXACIN HYDROCHLORIDE
ManufacturerCIPROFLOXACIN HYDROCHLORIDE
Original Package?1
Active SubstanceCIPROFLOXACIN HYDROCHLORIDE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity7 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC61314-656
Drug UPC0361314656100
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 Identifier4BA73M5E37
Drug Application NumberNDA019992
Structured Product Labeling (SPL ID)d0fcd267-50bf-4140-a186-3b3e9bca93bd
Structured Product Labeling (SPL Set ID)ab52b14d-345b-47ff-a832-465caddd3801
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