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Home Prescription medicine SUN PHARMACEUTICAL INDUSTRIES INC — Febuxostat…

Food & drug recall · FDAJanuary 18, 2024Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle

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

What’s wrong

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

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: SUN PHARMACEUTICAL INDUSTRIES INC

The product

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.

Details

Units affected
19,992 bottles
Recall date
January 18, 2024
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Model, lot or SKU numbers
Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
Where it was distributed

Nationwide in the USA

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: SUN PHARMACEUTICAL INDUSTRIES INC — Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, D

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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