Meitheal Pharmaceuticals Inc. is recalling 1,160 ten-pack cartons of Glycopyrrolate Injection, USP (4mg per 20mL). This prescription medication is being recalled because it failed testing for impurities and degradation specifications, which means the drug may contain substances that do not meet quality standards. The recall affects 20 mL multi-dose vials distributed nationwide across the United States and India with expiration dates ranging from December 2021 to January 2023. Consumers should consult their healthcare provider or pharmacist regarding the use of this medication.
The presence of impurities or degradation products beyond established limits can potentially reduce the effectiveness of the medication or cause unexpected side effects, although no specific injuries or adverse events have been reported in this notice.
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Sources: FDA iRES · Raw API Response
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