HALOBETASOL PROPIONATE Recall D-0688-2022
Description: Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
HALOBETASOL PROPIONATE Recall D-0688-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0688-2022 |
| Event ID | 89798 |
| Brand | HALOBETASOL PROPIONATE |
| Generic Name | HALOBETASOL PROPIONATE OINTMENT |
| Manufacturer | HALOBETASOL PROPIONATE OINTMENT |
| Original Package? | 1 |
| Active Substance | HALOBETASOL PROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 35,185 tubes |
| 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 | 70512-033 |
| Drug UPC | 0370512033507 |
| 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 | 91A0K1TY3Z |
| Drug Application Number | ANDA209978 |
| Structured Product Labeling (SPL ID) | b8b88fbe-73bf-52ef-e053-2995a90ae826 |
| Structured Product Labeling (SPL Set ID) | 81ab198c-96ff-ce4b-e053-2a91aa0aaf61 |
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