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Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila He...

FDA Recall #D-0543-2024 — Class III — May 16, 2024

Recall #D-0543-2024 Date: May 16, 2024 Classification: Class III Status: Ongoing

Product Description

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8

Reason for Recall

Failed Impurities/Degradation Specifications.

Recalling Firm

Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

13,440 units

Distribution

Nationwide within the United States

Code Information

Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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