Glycopyrrolate Tablets Recalled for Failed Impurities and Degradation Specifications
Glycopyrrolate tablets distributed nationwide are being recalled due to failed impurities and degradation specifications. Patients with affected lots should discontinue use and consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a pharmaceutical quality control failure (impurities and degradation) in a Class II recall with no reported illnesses or injuries. This represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for a High severity rating.
Plain-English summary
Aurolife Pharma, LLC is recalling Glycopyrrolate Tablets, USP, 1 mg. The recall affects 7,344 bottles distributed nationwide in the United States and Puerto Rico.
The recall was initiated due to the failure of certain batches to meet impurities and degradation specifications required for pharmaceutical products.
Patients and healthcare providers with Glycopyrrolate from lots 01422002A1 (expiration 12/2023) and 01421078A3 (expiration 09/2023) should discontinue use. Patients should contact their healthcare provider or pharmacy to ensure continuity of care and obtain a replacement supply if needed.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Aurolife Pharma, LLC
- Category
- Drug
- Hazard
- Affected units
- 7,344
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 (4)
- Lots: 01422002A1
- Expiry: 12/2023
- 01421078A3
- Expiry: 09/2023
UPCs (1)
- 0313107014017
Distribution
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