Glycopyrrolate 1 mg Tablets Recalled for Failed Impurity Specifications
AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.
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: FDA Class II recalls address potential serious health consequences. Although no illnesses or injuries have been reported, unknown impurities in a pharmaceutical product represent a risk-of-harm situation.
Plain-English summary
AVKARE LLC is recalling Glycopyrrolate Tablets, USP, 1 mg in unit dose cartons (lot numbers 43313 and 43342, expiring 12/2023) because the product failed quality specifications related to unknown impurities. The affected product was distributed nationwide in the United States.
The recall is based on failed quality specifications. Patients who have received glycopyrrolate from the recalled lot numbers should consult their healthcare provider or pharmacist.
Healthcare providers and pharmacists with the affected product should verify lot numbers and quarantine any affected cartons.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- AVKARE LLC
- Category
- Drug
- Hazard
- Affected units
- 1,237
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 (3)
- Lot#: 43313
- 43342
- Exp 12/2023
Distribution
Distributed nationwide across the United States.
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