Prescription eye irrigating solution recalled due to manufacturing temperature control deviations
McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide because of temperature control failures during manufacturing that violate cGMP standards.
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 with no reported illnesses or injuries. The temperature abuse during manufacturing represents a control deviation for a sterile product, which is a risk-of-harm scenario, but actual harm has not been reported. Per the rubric, risk-of-harm products with no reported injury are classified as High severity.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling BSS sterile irrigating solution (balanced salt solution), a prescription ophthalmic product, because of temperature abuse during manufacturing that violates cGMP standards.
The recalled product is a 15 mL bottle of BSS Sterile Irrigating Solution manufactured by Alcon Surgical Inc. and distributed nationwide in the USA. Temperature control deviations occurred during the manufacturing process.
Thirteen bottles have been identified as affected by this temperature abuse. Because specific lot numbers cannot be matched to individual consignees, customers were notified with information about shipment dates that may correspond to the affected product.
Customers who received BSS sterile irrigating solution should consult the distribution dates provided by McKesson Medical-Surgical to determine if they have received product from this recall. Contact your supplier or McKesson Medical-Surgical Inc. for verification and guidance.
The recalled product
- Product
- BSS (BALANCED SALT SOLUTION)
- Brand
- BSS
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-abuse
- manufacturing-deviation
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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