The Recall Desk
HighFDA (Drugs)·D-0091-2023·Announced 2023-01-04

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.

What this means for you

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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Same hazard · unknown impurities

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