VistaPharm, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx on…

Recall date

August 17, 2017

Source

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

Recall number

D-1139-2017

FDA classification

Class III

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide

Why it was recalled

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16