Recall Enforment Report D-0426-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by US Pharmaceuticals Inc., originally initiated on 12-07-2018 for the product Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03 The product was recalled due to gmp deviations: out of specification results for total aerobic microbial count in excipient purified water sample. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0426-2019 | 12-07-2018 | 02-13-2019 | Class II | 67848 units | Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | Terminated |
| D-0425-2019 | 12-07-2018 | 02-13-2019 | Class II | 19752 units | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | Terminated |
| D-0427-2019 | 12-07-2018 | 02-13-2019 | Class II | 7020 units | Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060. | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | Terminated |
