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
Reported: April 4, 2018 Initiated: February 26, 2018 #D-0608-2018
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
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.
Details
- Recalling Firm
- Paddock Laboratories, LLC.
- Units Affected
- 52,596 bottles
- Distribution
- Nationwide within the USA.
- Location
- New Hope, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Paddock Laboratories, LLC.. Units affected: 52,596 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 4, 2018. Severity: Moderate. Recall number: D-0608-2018.
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