Drug product
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
D-0464-2023
Product summary
- Firm
- Padagis US LLC
- Event
- Event 91771
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 43,238 cartons
- Official record key
drug-enforcement:D-0464-2023
Official wording
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.
Code information: Lot# SCDR, Exp 02/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications