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.
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: 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
- temperature-abuse
- manufacturing-defect
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.
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