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Cough Medicine Recalled


November 21, 2019

KVK-Tech Inc. is voluntarily recalling 1534 bottles of hydrocodone bitartrate and homatropine methylbromide oral solution, 5 mg/1.5 mg per 5 mL. According to the November 20, 2019, US Food and Drug Administration (FDA) Enforcement Report, black particles were found in samples of the solution during inspections.

The recall affects 473-mL bottles of hydrocodone bitartrate and homatropine methylbromide oral solution (NDC 10702-150-16) from two lots: 14375A (Exp. 12/19) and 14398A (Exp. 1/20). The recalled medicine was distributed within the United States. 

KVK-Tech initiated the recall November 1, 2019. The FDA has not yet issued a recall classification. 

Hydrocodone bitartrate and homatropine methylbromide oral solution is a prescription cough medicine.

Jolynn Tumolo

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