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

Mckesson Medical-Surgical Inc. Corporate Office: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36

Is my product affected?

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36

  • Brand NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

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

What happened

McKesson Medical-Surgical is recalling Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment (3.5 g tubes) manufactured by Sandoz due to temperature abuse during storage that violated manufacturing standards. A total of 120 tubes were distributed nationwide across the United States. Because McKesson cannot identify which specific lot numbers went to individual customers, recall notices were sent to customers with the distribution date and the dates when affected product may have been shipped to them.

The source document does not specify what affected consumers should do regarding 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: 120 tubes 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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