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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50

Is my product affected?

BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50

  • Brand BSS

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling BSS Sterile Irrigating Solution (balanced salt solution) in 500 mL bottles manufactured by Alcon Surgical Inc. The recall affects a total of 4 bottles distributed nationwide across the USA. The products are being recalled due to cGMP (current Good Manufacturing Practice) deviations related to temperature abuse.

McKesson Medical-Surgical was unable to identify the specific lot numbers received by individual customers for these recalled prescription products. Customers who received distribution letters will find information about when the product was distributed to them and the dates when the affected product may have been shipped. The recall record does not specify a remedy or required action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 4 bottles Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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