Drug product
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
D-0736-2022
Product summary
- Event
- Event 89869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4080 bottles
- Official record key
drug-enforcement:D-0736-2022
Official wording
Reason: Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Code information: Lot: 01421008A1, Exp 03/2023
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance