Drug product

Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,

D-1727-2019

July 11, 2019

Class II

Product summary

Firm: US Pharmaceuticals Inc.
Event: Event 83316
Status: Terminated
Classification: Class II
Quantity: 76 cases
Official record key: drug-enforcement:D-1727-2019

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 #88J17 EXP 07/2019

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of Specification