Recalls / Class II
Class IID-0091-2023
Product
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Oral
- NDC
- 50268-363
- FDA application
- ANDA202675
- Affected lot / code info
- Lot#: 43313, 43342, Exp 12/2023
Why it was recalled
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Recalling firm
- Firm
- AVKARE LLC
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1237 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2022-12-28
- Posted by FDA
- 2023-01-04
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0091-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.