ECONAZOLE NITRATE Recall D-0682-2022
Description: Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
ECONAZOLE NITRATE Recall D-0682-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0682-2022 |
| Event ID | 89798 |
| Brand | ECONAZOLE NITRATE |
| Generic Name | ECONAZOLE NITRATE |
| Manufacturer | ECONAZOLE NITRATE |
| Original Package? | 1 |
| Active Substance | ECONAZOLE NITRATE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 151,975 tubes |
| 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 | 52565-022 |
| 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 | H438WYN10E |
| Drug Application Number | ANDA076574 |
| Structured Product Labeling (SPL ID) | 4fbee603-de52-4aec-b5eb-8cf29a8a01db |
| Structured Product Labeling (SPL Set ID) | 51fd5746-8313-4f68-b929-8481ad8ca241 |
| Similar To |