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

Mckesson Medical-Surgical Inc. Corporate Office: Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10

Is my product affected?

Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10

  • Brand SODIUM BICARBONATE ANTACID

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

What happened

McKesson Medical-Surgical Inc. is recalling Sodium Bicarbonate Tablets, 600 mg, in 1000-count bottles manufactured by Major Pharma. The recall affects one bottle per customer nationwide due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during storage or handling. The product has NDC number 0536-1047-10.

Because McKesson cannot identify the specific lot numbers received by individual customers, affected consumers should refer to the distribution dates included in their recall notification letter to determine if their product may be impacted. The source does not specify what action consumers should take regarding the 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: 1 bottle/1000 tablets per bottle 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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