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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), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15

Is my product affected?

BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15

  • 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, a prescription balanced salt solution product sold in 15 mL bottles and manufactured by Alcon Surgical Inc. The recall involves 13 bottles distributed nationwide across the United States. The product is being recalled due to current Good Manufacturing Practice (cGMP) deviations related to temperature abuse during handling or storage.

Because McKesson Medical-Surgical is unable to identify which specific lot numbers were received by individual customers, affected consumers should refer to the distribution letter they received, which includes the dates the product was distributed and the timeframe when impacted product may have been shipped to them. The source document does not specify what action consumers should take regarding recalled product in their possession.

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: 13 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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