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

Mckesson Medical-Surgical Inc. Corporate Office: Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

Is my product affected?

Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

  • Brand ISOPTO ATROPINE

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

What happened

McKesson Medical-Surgical is recalling Isopto Atropine (atropine sulfate ophthalmic solution) 1% in 5mL bottles manufactured by Alcon Surgical. The recall affects 13 bottles distributed nationwide across the United States. The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse of the product.

McKesson Medical-Surgical cannot identify which specific lot numbers were received by individual customers. The company provided each customer with the date their product was distributed and the date range when affected product may have been shipped to them. The source does not specify what actions affected consumers should take regarding this recalled product.

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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