PlainRecalls
FDA Drug Moderate Class II Terminated

Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25,

Reported: August 21, 2019 Initiated: July 11, 2019 #D-1728-2019

Product Description

Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25,

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
98 cases
Distribution
Distributed Nationwide in the USA
Location
Belleville, NJ

Frequently Asked Questions

What product was recalled?
Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25,. Recalled by US Pharmaceuticals Inc.. Units affected: 98 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-1728-2019.