Apraclonidine ophthalmic solution recalled for temperature-abuse manufacturing defect
McKesson Medical-Surgical is recalling 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.
What this means for you
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 is an FDA Class II recall for manufacturing deviations (temperature abuse) that could affect drug efficacy. No illnesses or injuries have been reported. Per the severity rubric, FDA Class II without hospitalization reports with potential risk of harm scores as High (3).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Apraclonidine Ophthalmic Solution 0.5%, a prescription ophthalmic medication manufactured by Sandoz Pharma. The recall affects 21 bottles of 5 mL product size distributed nationwide in the United States.
The recall was initiated due to cGMP deviations involving temperature abuse during manufacturing. Exposure to improper temperatures may compromise the chemical stability and efficacy of the medication.
Customers and healthcare providers who received this product have been notified by letter, with information regarding the distribution dates associated with the recalled shipment. Patients taking this medication should contact their healthcare provider or pharmacist for further guidance on their treatment.
The recalled product
- Product
- APRACLONIDINE (APRACLONIDINE)
- Brand
- APRACLONIDINE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0361314665058
- 0361314665102
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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