BETAMETHASONE DIPROPIONATE Recall D-0669-2022
Description: Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
BETAMETHASONE DIPROPIONATE Recall D-0669-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0669-2022 |
| Event ID | 89798 |
| Brand | BETAMETHASONE DIPROPIONATE |
| Generic Name | BETAMETHASONE DIPROPIONATE |
| Manufacturer | BETAMETHASONE DIPROPIONATE |
| Original Package? | 1 |
| Active Substance | BETAMETHASONE DIPROPIONATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 43,218 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 | 52565-023 |
| Drug UPC | 0352565023292 |
| 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 | 826Y60901U |
| Drug Application Number | ANDA206389 |
| Structured Product Labeling (SPL ID) | 3e7bbd47-5cf6-4aac-9653-271bf6e4d584 |
| Structured Product Labeling (SPL Set ID) | 3b4b9e5a-769d-7034-c381-6796837a2e24 |
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