PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 21, 2019 Initiated: July 11, 2019 #D-1736-2019

Product Description

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

Reason for Recall

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Details

Recalling Firm
US Pharmaceuticals Inc.
Units Affected
1174 cases
Distribution
Distributed Nationwide in the USA
Location
Belleville, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by US Pharmaceuticals Inc.. Units affected: 1174 cases.
Why was this product recalled?
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1736-2019.