Product Safety Recalls

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NAPHAZOLINE HYDROCHLORIDE Recall D-1313-2022

Description: Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.

NAPHAZOLINE HYDROCHLORIDE Recall D-1313-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1313-2022
Event ID90553
BrandNAPHCON A
Generic NameNAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
ManufacturerNAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Original Package?1
Active SubstanceNAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity12 boxes
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0065-0085
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 IdentifierMZ1131787D NYW905655B
Drug Application NumberNDA020226
Structured Product Labeling (SPL ID)fe43207e-46ec-4284-b54f-c279edba278b
Structured Product Labeling (SPL Set ID)4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58
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