ESTRADIOL Recall D-0464-2023
Description: Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
ESTRADIOL Recall D-0464-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0464-2023 |
| Event ID | 91771 |
| Brand | EVAMIST |
| Generic Name | ESTRADIOL |
| Manufacturer | ESTRADIOL |
| Original Package? | 1 |
| Active Substance | ESTRADIOL |
| Drug Route | TRANSDERMAL |
| Distribution | Nationwide in the USA |
| Quantity | 43,238 cartons |
| Recall Reason | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. |
| Drug Classification | Class III |
| Drug Code Info | 20230322 |
| Product NDC | 0574-2067 |
| Product NUI | M0447348 N0000175825 N0000000100 |
| Pharma Class (EPC) | Estrogen [EPC] |
| Pharma Class (CS) | Estradiol Congeners [CS] |
| Recall Initiation Date | 20230221 |
| Report Date | 20230322 |
| Classification Date | 20230310 |
| Address | 3940 Quebec Ave N Minneapolis, MN 55427-1244 United States |
| Recalling Firm | Padagis US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4TI98Z838E |
| Drug Application Number | NDA022014 |
| Structured Product Labeling (SPL ID) | ac181fb3-5268-4105-b41d-a39d41edc630 |
| Structured Product Labeling (SPL Set ID) | 9a0aa631-133d-406b-9d32-8a1a99af4e50 |
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