Ophthalmic Drug Isopto Atropine Recalled Due to Manufacturing Temperature Deviation
McKesson Medical-Surgical is recalling 13 bottles of Isopto Atropine 1% ophthalmic solution due to temperature-abuse violations of manufacturing standards that may have affected product sterility.
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: FDA Class II recall with manufacturing quality deviations but no reported illnesses or injuries. Temperature abuse of a sterile pharmaceutical product presents potential quality and sterility risk without confirmed adverse events, fitting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottles (NDC 0065-0303-55), manufactured by Alcon Surgical. The recall encompasses 13 bottles distributed nationwide to healthcare providers and facilities.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. These deviations may have affected the sterility and efficacy of the recalled product.
Healthcare providers and pharmacies that received affected bottles should discontinue use immediately. Because the manufacturer could not identify specific lot numbers for individual recipients, providers should refer to distribution dates in their recall notification letters. Patients currently using this product should consult their healthcare provider for guidance and alternative treatments.
The recalled product
- Product
- ISOPTO ATROPINE (ATROPINE SULFATE)
- Brand
- ISOPTO ATROPINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 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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