The Recall Registry
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Home Prescription medicine Denison Pharmaceuticals, LLC — Adult Cough and…

Food & drug recall · FDASeptember 25, 2024Labelling issue

Denison Pharmaceuticals, LLC — Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons

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

What’s wrong

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

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: Denison Pharmaceuticals, LLC

The product

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

Details

Units affected
72,648 bottles
Recall date
September 25, 2024
Brand
Denison Pharmaceuticals, LLC
Model, lot or SKU numbers
Lot# 0104V, Exp 07/20250106V, Exp 09/2024
Barcodes (UPC)
850015736155
Where it was distributed

Product was distributed to two accounts that may have distributed the product further to the Retail Level

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: Denison Pharmaceuticals, LLC — Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9,

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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