CLOBETASOL PROPIONATE Recall D-0674-2022
Description: Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
CLOBETASOL PROPIONATE Recall D-0674-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0674-2022 |
| Event ID | 89798 |
| Brand | CLOBETASOL PROPIONATE |
| Generic Name | CLOBETASOL PROPIONATE |
| Manufacturer | CLOBETASOL PROPIONATE |
| Original Package? | 1 |
| Active Substance | CLOBETASOL PROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 81,883 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 | 52565-082 |
| 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 | ANDA208881 |
| Structured Product Labeling (SPL ID) | 9fe1fe25-3ee4-4426-ba64-a5d2c2545b80 |
| Structured Product Labeling (SPL Set ID) | 16035e8f-8570-f91e-f766-a68c34811cbc |
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