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Cough Medicine Recalled

Jolynn Tumolo

KVK Tech Inc is recalling nearly 18,000 bottles of hydrocodone bitartrate and homatropine methylbromide tablets because the drug failed to meet impurities/degradation specifications, according to the May 26, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects hydrocodone bitartrate and homatropine methylbromide tablets, 5 mg/1.5 mg, 30-count bottles (NDC 10702-055-03), manufactured by KVK Tech Inc., Newtown, PA, from lot 15684A (Exp. 7/21). The tablets were distributed throughout the United States. 

KVK Tech voluntarily initiated the recall April 27, 2021. On May 17, 2021, the FDA designated the recall Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.

Hydrocodone bitartrate and homatropine methylbromide tablets are available with a prescription for cough relief in adults.

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