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Home Prescription medicine Zydus Pharmaceuticals (USA) Inc — Estradiol…

Food & drug recall · FDAMay 16, 2024Labelling issue

Zydus Pharmaceuticals (USA) Inc — Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Failed Impurities/Degradation Specifications.

The Recall Registry rates this labelling issueFDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Zydus Pharmaceuticals (USA) Inc

The product

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

Details

Units affected
13,440 units
Recall date
May 16, 2024
Brand
Zydus Pharmaceuticals (USA) Inc
Model, lot or SKU numbers
Lot #: M311202, Exp. Date 2/25M311201, Exp. Date 1/25
Where it was distributed

Nationwide within the United States

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Zydus Pharmaceuticals (USA) Inc — 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, N

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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