HYDROCORTISONE BUTYRATE Recall D-0692-2022
Description: Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
HYDROCORTISONE BUTYRATE Recall D-0692-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0692-2022 |
| 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 | 30,497 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 | 52565-087 |
| 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) | a0963357-1034-43ee-81bb-9c249fa29de3 |
| Structured Product Labeling (SPL Set ID) | 97d35248-b28b-18b0-98a6-2d93476fb4a3 |
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