Drug product

CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4

D-1724-2019

July 11, 2019

Class II

Product summary

Firm: US Pharmaceuticals Inc.
Event: Event 83316
Status: Terminated
Classification: Class II
Quantity: 144 cases
Official record key: drug-enforcement:D-1724-2019

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 52J17, 53J17, 54J17, 55J17, 59J17, 60J17 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