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

Mckesson Medical-Surgical Inc. Corporate Office: E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01

Is my product affected?

E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01 (current)

  • Brand E-Z-GAS

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

What happened

McKesson Medical-Surgical Inc. is recalling E-Z-Gas II, Effervescent Granules (4 g packets, 50 packets per box) manufactured by Bracco Diagnostics Inc. due to cGMP deviations involving temperature abuse. The recall affects 16 boxes totaling 800 pouches distributed nationwide across the United States. McKesson is unable to identify which specific lot numbers were received by individual customers, but has provided distribution dates to customers indicating when affected product may have been shipped to them.

The source does not specify a remedy or corrective action for affected 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: 16 boxes/50 pouches per box 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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