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.
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
What was recalled
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
- Recalling firm
- Alvogen, Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1607-2014
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.
Other Acetaminophen recalls
See all
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.
Class II · Moderate risk Ongoing
Tylenol
Reason Defective Container
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.
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL
Reason Discoloration
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.