Why it was recalled
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Product description
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
Lot numbers, UPCs & expiration codes
Lot: MEEF Exp. 04/2020
Where it was sold
Nationwide within 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-0608-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2018
- FDA report date
- Apr 4, 2018
- Quantity
- 52,596 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Paddock Laboratories, LLC.
Original FDA data
Every field from FDA enforcement report D-0608-2018, exactly as published.
Show all FDA fields
- City
- New Hope
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 79334
- Address
- 3940 Quebec Ave N
- Code information
- Lot: MEEF Exp. 04/2020
- Postal code
- 55427-1244
- Report date
- Apr 4, 2018
- Product type
- Drugs
- Recall number
- D-0608-2018
- Classification
- Class II
- Recalling firm
- Paddock Laboratories, LLC.
- Product quantity
- 52,596 bottles
- Termination date
- Jul 16, 2020
- Reason for recall
- Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
- Distribution pattern
- Nationwide within the USA.
- Recall initiation date
- Feb 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2018