Drug Enforcement D-0464-2023

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.

Status

Ongoing

Classification

Class III

Report Date

March 22, 2023

Termination Date

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Product Information

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
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Padagis US LLC
Address
3940 Quebec Ave N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0464-2023
Event ID
91771
Recall initiation date
February 21, 2023
Center classification date
March 10, 2023
Code info
Lot# SCDR, Exp 02/2024
More code info
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