Bracco Recalls E-Z-GAS Antacid Due to Subpotent Drug Levels
Bracco Diagnostic Inc is recalling E-Z-GAS antacid packets because routine stability testing found the drug to be subpotent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Bracco Diagnostic Inc is recalling 58,050 packets of E-Z-GAS (Antacid/Antiflatulent) effervescent granules. The product is identified by Lot # F12C01 and has an expiration date of 02/15. The recall was initiated because routine stability testing at 24 months resulted in an out-of-specification (OOS) finding, indicating the drug was subpotent.
The affected product is a prescription-only medication manufactured in the USA for E-Z EM, Inc. by Tower Laboratories LTD. The recall is classified as Class III by the FDA, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected E-Z-GAS packets and contact their healthcare provider or the recalling firm for further instructions. The product was distributed nationwide.
The recalled product
- Product
- E-Z-GAS (ANTACID/ANTIFLATULENT)
- Brand
- E-Z-GAS
- Manufacturer
- Bracco Diagnostic Inc
- Category
- Drug — Antacid
- Hazard
- Affected units
- 58,050
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # F12C01
- Exp. 02/15
Distribution
Distributed nationwide across the United States.
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