Why it was recalled
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.
Product 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
Lot numbers, UPCs & expiration codes
Lot# SCDR, Exp 02/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0464-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 21, 2023
- FDA report date
- Mar 22, 2023
- Quantity
- 43,238 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0464-2023, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 91771
- Address
- 3940 Quebec Ave N
- Code information
- Lot# SCDR, Exp 02/2024
- Postal code
- 55427-1244
- Report date
- Mar 22, 2023
- Product type
- Drugs
- Recall number
- D-0464-2023
- Classification
- Class III
- Recalling firm
- Padagis US LLC
- Product quantity
- 43,238 cartons
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 10, 2023