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

Food & drug recall · FDAJune 21, 2024Serious

Zydus Pharmaceuticals (USA) Inc — Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahm

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

What’s wrong

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health 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

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

Details

Units affected
a) 13,128 bottles; b) 252 bottles
Recall date
June 21, 2024
Brand
Zydus Pharmaceuticals (USA) Inc
Model, lot or SKU numbers
Lot #: a) M213175, Exp. Date 09/2024b) M213176, Exp. Date 09/2024
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 — Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahm

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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