Drug product
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
D-1312-2022
Product summary
- Event
- Event 90553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 boxes
- Official record key
drug-enforcement:D-1312-2022
Official wording
Reason: CGMP Deviations: products were stored outside the drug label specifications.
Code information: Part# 444-01-HST
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations