Class III
Ongoing
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
This recall is currently active, issued March 22, 2023. It was issued by Padagis Us Llc.
- Company
- Padagis Us Llc
- Recall Initiated
- February 21, 2023
- Posted
- March 22, 2023
- Recall Number
- D-0464-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 43,238 cartons
- Firm Location
- Minneapolis, MN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide in the USA
Lot / Code Info
Lot# SCDR, Exp 02/2024
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