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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1313-2022 |
Event ID | 90553 |
Brand | NAPHCON A |
Generic Name | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
Manufacturer | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
Original Package? | 1 |
Active Substance | NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE |
Drug Route | OPHTHALMIC |
Distribution | Nationwide in the USA. |
Quantity | 12 boxes |
Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
Drug Classification | Class II |
Drug Code Info | 20220817 |
Product NDC | 0065-0085 |
Recall Initiation Date | 20220629 |
Report Date | 20220817 |
Classification Date | 20220805 |
Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
Initial Notification | Letter |
Unique Ingredient Identifier | MZ1131787D NYW905655B |
Drug Application Number | NDA020226 |
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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