OTC Antacid E-Z-GAS Recalled for Manufacturing Temperature Control Deviations
McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is a manufacturing process control failure (temperature abuse causing cGMP deviations) with theoretical product quality impact, qualifying as a precautionary recall.
Plain-English summary
E-Z-GAS II Effervescent Granules, an over-the-counter antacid and antiflatulent product manufactured by Bracco Diagnostics Inc., is being recalled nationwide. The product is sold as 4-gram packets packaged with 50 packets per box. Affected NDC numbers are 0270-9020-01 (discontinued) and 10361-793-01 (current), distributed by McKesson Medical-Surgical Inc.
The recall was issued due to cGMP (current Good Manufacturing Practice) deviations resulting from temperature abuse during the manufacturing process. Temperature control failures during manufacturing can compromise product integrity and consistency.
Consumers who have purchased this product should discontinue use. McKesson Medical-Surgical Inc. has notified direct customers regarding the recall with information about shipment dates. Because specific lot numbers cannot be identified for individual consignees, all product from the affected NDCs distributed during the relevant period should be considered subject to this recall. Consumers with questions should consult their healthcare provider or pharmacist.
The recalled product
- Product
- E-Z-GAS (ANTACID/ANTIFLATULENT)
- Brand
- E-Z-GAS
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — OTC Antacid
- Hazard
- gmp-deviation
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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