Home / Recalls / Padagis US LLC / D-0464-2023

D-0464-2023 Class III Ongoing

Recalled by Padagis US LLC — Minneapolis, MN

Recall Details

Product Type
Drugs
Report Date
March 22, 2023
Initiation Date
February 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,238 cartons

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

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 Pattern

Nationwide in the USA

Code Information

Lot# SCDR, Exp 02/2024

Other recalls by Padagis US LLC

  • D-0246-2025 Class II — Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use (February 6, 2025)
  • D-0048-2025 Class III — Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufa (October 11, 2024)
  • D-0139-2024 Class II — Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx O (November 1, 2023)
  • D-0081-2024 Class II — Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-f (September 28, 2023)
  • D-1497-2022 Class II — Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Per (August 17, 2022)
  • D-0372-2022 Class II — Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles (December 27, 2021)