FLUTICASONE PROPIONATE Recall D-1172-2022
Description: Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
FLUTICASONE PROPIONATE Recall D-1172-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1172-2022 |
| Event ID | 90405 |
| Brand | FLUTICASONE PROPIONATE |
| Generic Name | FLUTICASONE PROPIONATE |
| Manufacturer | FLUTICASONE PROPIONATE |
| Original Package? | 1 |
| Active Substance | FLUTICASONE PROPIONATE |
| Drug Route | NASAL |
| Distribution | Nationwide USA |
| Quantity | 44,400 bottles |
| Recall Reason | Defective container: defect prevents product from dispensing as intended. |
| Drug Classification | Class II |
| Drug Code Info | 20220706 |
| Product NDC | 50383-700 |
| Recall Initiation Date | 20220613 |
| Report Date | 20220706 |
| Classification Date | 20220630 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | O2GMZ0LF5W |
| Drug Application Number | ANDA077570 |
| Structured Product Labeling (SPL ID) | 4f61c3c9-e855-4c87-a257-ed2860c866e3 |
| Structured Product Labeling (SPL Set ID) | b7ea1841-2fb1-48c8-86f9-639893fd1a84 |
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