Drug product
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
D-0300-2026
Product summary
- Event
- Event 98156
- Status
- Ongoing
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0300-2026
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications