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Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10...

FDA Recall #D-0526-2022 — Class II — January 26, 2022

Recall #D-0526-2022 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00

Reason for Recall

CGMP Deviations

Recalling Firm

ULTRAtab Laboratories, Inc. — Highland, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

639,729 tablets

Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

Code Information

Product Codes: C119L Bulk Lots: 18K028

Status

Terminated

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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