CLOBETASOL PROPIONATE Recall D-0672-2022
Description: Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
CLOBETASOL PROPIONATE Recall D-0672-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0672-2022 |
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 | 35,180 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 | 52565-055 |
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 | ANDA208667 |
Structured Product Labeling (SPL ID) | 4533cb56-c0eb-4541-885c-001b4f8bc9e9 |
Structured Product Labeling (SPL Set ID) | a12c2b51-710d-68cd-2531-1c28f9864d8f |
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