D-1734-2019 Class II Terminated
FDA drug recall D-1734-2019 was initiated by US Pharmaceuticals Inc. on July 11, 2019 and is designated Class II. 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. The recall status is terminated (terminated June 25, 2020). Affected quantity: 651 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 651 cases
Product Description
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #56J17 EXP 07/2019