CLOBETASOL PROPIONATE Recall D-0700-2022
Description: Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
CLOBETASOL PROPIONATE Recall D-0700-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0700-2022 |
| Event ID | 89798 |
| Brand | CLOBETASOL PROPIONATE CREAM |
| Generic Name | CLOBETASOL PROPIONATE CREAM |
| Manufacturer | CLOBETASOL PROPIONATE CREAM |
| Original Package? | 1 |
| Active Substance | CLOBETASOL PROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 26,326 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 | 70512-028 |
| Drug UPC | 0370512028602 |
| 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 | 779619577M |
| Drug Application Number | ANDA209974 |
| Structured Product Labeling (SPL ID) | b8bc7e18-cd15-7cb2-e053-2a95a90a2f01 |
| Structured Product Labeling (SPL Set ID) | 8195648e-a744-337d-e053-2991aa0a86c2 |
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