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.