US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 30, 2012 (14 years ago)

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Impurities/Degradation Products: exceeded specification at 3 month stability testing

What was recalled

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.

Recalling firm
VistaPharm, Inc.
NDC code
66689-023-16
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1416-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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