HYDROCORTISONE BUTYRATE Recall D-0690-2022
Description: Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
HYDROCORTISONE BUTYRATE Recall D-0690-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0690-2022 |
| Event ID | 89798 |
| Brand | HYDROCORTISONE BUTYRATE |
| Generic Name | HYDROCORTISONE BUTYRATE |
| Manufacturer | HYDROCORTISONE BUTYRATE |
| Original Package? | 1 |
| Active Substance | HYDROCORTISONE BUTYRATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 6431 bottles |
| Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 51862-159 |
| Recall Initiation Date | 20220315 |
| Report Date | 20220330 |
| Classification Date | 20220321 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 05RMF7YPWN |
| Drug Application Number | ANDA209556 |
| Structured Product Labeling (SPL ID) | 5cc0fa38-756a-4fe1-9e2e-789273ed8014 |
| Structured Product Labeling (SPL Set ID) | 2181eba7-32f9-4187-8940-b3c0588e1c5e |
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