This recall involves Glycopyrrolate (1 mg) tablets, a prescription medication used to treat peptic ulcers. The 100-count bottles, distributed by Aurobindo Pharma USA, Inc., are being recalled because the tablets failed to meet quality standards for impurities and degradation. No injuries or adverse health events have been reported to date.
The tablets failed to meet chemical impurity specifications, which means the product does not meet the manufacturer's quality and potency standards. While this is a Class III recall (the least severe category), using the affected medication could result in receiving a product that has degraded over time.
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Recall number: D-0877-2023. Distributed by Aurobindo Pharma USA, Inc.
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Sources: FDA iRES · Raw API Response
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