Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Endocet (oxycodone and acetaminophen)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
Affected NDC
60951-0797-70
Compare with the code on your package — it is the most precise check available.
Drug: Acetaminophen Category: Pain Relief & OTC Medication
- Recalling firm
- Endo Pharmaceuticals, Inc.
- NDC code
- 60951-797-70
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1381-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acetaminophen recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
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
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Other recalls by Endo Pharmaceuticals, Inc.
All 2012 recalls
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Class II · Moderate risk
Calcitonin Salmon Nasal Spray
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class I · High risk
robaxin-750
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
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