The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1026-2022·Announced 2022-06-15

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.

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 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
Hazard
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.

See all 130 products in this recall →

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