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

Mckesson Medical-Surgical Inc. Corporate Office: Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05

Is my product affected?

Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05

  • Brand APRACLONIDINE

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

What happened

McKesson Medical-Surgical is recalling Aparaclonidine Ophthalmic Solution 0.5% in 5 mL bottles (manufactured by Sandoz Pharma) distributed nationwide. The recall affects 21 bottles that were subject to temperature abuse, a deviation from proper manufacturing conditions. McKesson was unable to identify which specific lot numbers were affected at particular customer locations, but provided distribution and shipping date information to help identify potentially impacted product.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

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: 21 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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