DIFLORASONE DIACETATE Recall D-0681-2022
Description: Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
DIFLORASONE DIACETATE Recall D-0681-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0681-2022 |
| Event ID | 89798 |
| Brand | DIFLORASONE DIACETATE OINT |
| Generic Name | DIFLORASONE DIACETATE OINTMENT |
| Manufacturer | DIFLORASONE DIACETATE OINTMENT |
| Original Package? | 1 |
| Active Substance | DIFLORASONE DIACETATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 24,304 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 | 70512-031 |
| Drug UPC | 0370512031602 |
| 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 | 7W2J09SCWX |
| Drug Application Number | ANDA210753 |
| Structured Product Labeling (SPL ID) | b8b8c0e8-fb69-048b-e053-2a95a90afbbb |
| Structured Product Labeling (SPL Set ID) | 81a55188-1f73-c212-e053-2991aa0a0719 |
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