KVK-Tech, Inc. recalls Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd.…

Recall date

November 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0532-2020

FDA classification

Class II

Brand / firm

KVK-Tech, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16