Drug product
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
D-1071-2020
Product summary
- Event
- Event 85333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,352 bottles
- Official record key
drug-enforcement:D-1071-2020
Official wording
Reason: Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Code information: Lot # 32809101, Exp 3/2021
Distribution pattern: Product was distributed within the United States.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification