CALCIPOTRIENE HYDRATE Recall D-1170-2022
Description: Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
CALCIPOTRIENE HYDRATE Recall D-1170-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1170-2022 |
| Event ID | 90442 |
| Brand | CALCIPOTRIENE |
| Generic Name | CALCIPOTRIENE |
| Manufacturer | CALCIPOTRIENE |
| Original Package? | 1 |
| Active Substance | CALCIPOTRIENE HYDRATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the U.S. |
| Quantity | 2,736 Bottles |
| Recall Reason | Defective Delivery System: Potential defect that could prevent the product from dispensing as intended. |
| Drug Classification | Class II |
| Drug Code Info | 20220706 |
| Product NDC | 50383-732 |
| Recall Initiation Date | 20220610 |
| Report Date | 20220706 |
| Classification Date | 20220629 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | S7499TYY6G |
| Drug Application Number | ANDA077579 |
| Structured Product Labeling (SPL ID) | e2844787-f986-4554-bae1-9e4050695edc |
| Structured Product Labeling (SPL Set ID) | 53c9942a-e861-493f-95c2-53446bc5f06d |
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