Product Safety Recalls

Product Recall Tracker

DEXAMETHASONE Recall D-1102-2022

Description: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36

DEXAMETHASONE Recall D-1102-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1102-2022
Event ID89646
BrandNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Generic NameNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
ManufacturerNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Original Package?1
Active SubstanceDEXAMETHASONE NEOMYCIN SULFATE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity120 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC61314-631
Product NUIN0000175576 N0000175450
Drug UPC0361314631367
Pharma Class (EPC)Corticosteroid [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 Identifier7S5I7G3JQL 057Y626693
Drug Application NumberNDA050065
Structured Product Labeling (SPL ID)a3406db4-cee5-43b3-b9c1-63d01dccb2f7
Structured Product Labeling (SPL Set ID)7f2e3c46-9f39-45e7-99a9-64cc4f6f649d
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