Drug product
Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
D-1730-2019
Product summary
- Event
- Event 83316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 880 cases
- Official record key
drug-enforcement:D-1730-2019
Official wording
Reason: CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information: Lot #'s 68J17, 71J17, 72J17, 73J17, 77J17, 78J17, 79J17, 81J17, 82J17 - EXP 07/2019; 27P17, 28P17, 29P17, 30P17, 31P17, 32P17, 33P17, 37P17, 38P17, EXP 11/2019.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of Specification