Drug product

CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5

D-1736-2019

July 11, 2019

Class II

Product summary

Firm: US Pharmaceuticals Inc.
Event: Event 83316
Status: Terminated
Classification: Class II
Quantity: 1174 cases
Official record key: drug-enforcement:D-1736-2019

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 61J17, 62J17, 65J17, 66J17, 67J17, 83J17, 86J17, 87J17 EXP 07/2019; Lot #'s 06P17, 08P17, 09P17, 10P17, 12P17, 13P17, 15P17, 16P17, 17P17, 18P17, 19P17, 21P17, 22P17, 23P17, 24P17 , 26P17 EXP 11/2019

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