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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