CLOBETASOL PROPIONATE Recall D-0375-2022
Description: Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
CLOBETASOL PROPIONATE Recall D-0375-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0375-2022 |
| Event ID | 89241 |
| Brand | CLOBETASOL PROPIONATE |
| Generic Name | CLOBETASOL PROPIONATE |
| Manufacturer | CLOBETASOL PROPIONATE |
| Original Package? | 1 |
| Active Substance | CLOBETASOL PROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA. |
| Quantity | 96 tubes |
| Recall Reason | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria |
| Drug Classification | Class I |
| Drug Code Info | 20220119 |
| Product NDC | 51672-1258 51672-1294 51672-1259 |
| Recall Initiation Date | 20211215 |
| Report Date | 20220119 |
| Classification Date | 20220118 |
| Address | 3 Skyline Dr Hawthorne, NY 10532-2174 United States |
| Recalling Firm | Taro Pharmaceuticals U.S.A., Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 779619577M |
| Drug Application Number | ANDA074249 |
| Structured Product Labeling (SPL ID) | bc3a3472-55c3-44e8-89f1-9d66c198080a |
| Structured Product Labeling (SPL Set ID) | 4a761afb-a48a-4a5a-8700-ad93601a260f |
| Similar To |