FDA Drug recall D-1313-2022
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5…
- FDA Drug
- Class II
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5… by Mckesson Medical Surgical Corporate Office, citing CGMP Deviations: products were stored outside the drug label specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1313-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-29 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: products were stored outside the drug label specifications.
Identifiers
| ndc | 0065-0085-15 |
|---|---|
| ndc | 0065-0085-38 |
| ndc | 0065-0085-42 |
| ndc | 0065-0085-52 |
| ndc | 0065008515 |
| code_info | Part# 0065008515 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1313-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.