US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 18, 2017 (10 years ago)

Hydrocodone Bitartrate and Acetaminophen Oral Solution

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

Why it was recalled

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

What was recalled

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

Recalling firm
VistaPharm, Inc.
NDC code
66689-023-04
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0458-2017

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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Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0522-01 D-0255-2026
Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0523-01 D-0254-2026
Class II · Moderate risk Ongoing

Tylenol

Reason Defective Container

Kenvue Brands LLC D-0121-2026
Class II · Moderate risk Ongoing

Acetaminophen 500mg Caffeine 65mg caplets

Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Aero Healthcare NDC 55305-135-01 D-0155-2026