Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Reported: January 4, 2023 Initiated: December 22, 2022 #D-0091-2023
Product Description
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Reason for Recall
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Details
- Recalling Firm
- AVKARE LLC
- Units Affected
- 1237 cartons
- Distribution
- USA Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15. Recalled by AVKARE LLC. Units affected: 1237 cartons.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 4, 2023. Severity: Moderate. Recall number: D-0091-2023.
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