Eye Drops Recalled Due to Improper Storage Violating Manufacturing Standards
Naphcon A eye drops are being recalled nationwide because products were stored outside label specifications, violating Current Good Manufacturing Practice (CGMP) standards.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a CGMP deviation affecting storage conditions for a sterile ophthalmic drug. Although no illnesses or injuries have been reported, the manufacturing control failure and potential risk to product quality for a high-risk sterile product justify a High severity rating.
Plain-English summary
Naphcon A eye drops (containing Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%) are being recalled nationwide. The product is manufactured by Alcon, a Novartis company, and distributed as sterile eye drops in 15 mL bottles to relieve redness and allergic reactions.
The FDA issued a Class II recall after determining that products were stored outside the conditions specified on the drug label. This storage deviation violates Current Good Manufacturing Practice (CGMP) standards.
The recalled product was distributed nationwide in the United States. The recall number is D-1313-2022. Consumers with questions or concerns should contact their healthcare provider or pharmacist.
The recalled product
- Product
- NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE)
- Brand
- NAPHCON A
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part# 0065008515
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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