The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1034-2022·Announced 2022-06-15

FDA Recalls BSS Sterile Irrigating Solution for Manufacturing Temperature Deviations

McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.

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 for manufacturing defect (temperature abuse) to a sterile ophthalmic solution without reported illnesses or injuries. Temperature exposure poses a theoretical risk to product stability and sterility.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling BSS (Balanced Salt Solution) sterile irrigating solution nationwide. This is a 500 mL prescription ophthalmic (eye) irrigation solution manufactured by Alcon Surgical Inc. and distributed by McKesson.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. McKesson Medical-Surgical has issued recall notification letters that include the specific distribution and shipment dates relevant to each customer.

The recalled product

Product
BSS (BALANCED SALT SOLUTION)
Brand
BSS
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Ophthalmic Solution
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (1)

  • 0300650795159

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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