CLOBETASOL PROPIONATE Recall D-0673-2022
Description: Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
CLOBETASOL PROPIONATE Recall D-0673-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0673-2022 |
| 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 | 72,826 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 | 52565-039 |
| 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 | ANDA208589 |
| Structured Product Labeling (SPL ID) | e595ff4a-5878-4096-b05b-c50d5844ebc2 |
| Structured Product Labeling (SPL Set ID) | 1145ee2c-e7b4-1bd2-77fb-74245bbdef94 |
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