Drug recall D-1734-2019

Class II Terminated reported Aug 21, 2019

Product

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6

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.

Lots and codes

Lot #56J17 EXP 07/2019

Recall details

Recalling firm
US Pharmaceuticals Inc., Belleville, NJ
Quantity
651 cases
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 11, 2019
Terminated
June 25, 2020

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