FDAFDA · Food and drugs·Recall number D-0091-2023
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Published January 4, 2023 · Recall initiated: December 22, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications: Out of specification for unknown impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GLYCOPYRROLATE
- Manufacturer
- AVKARE LLC
- Distributor
- USA Nationwide
- Lot
- Lot#: 43313, 43342, Exp 12/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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