Endo Pharmaceuticals Recalls Endocet Tablets Due to Foreign Tablet Contamination
Endo Pharmaceuticals is recalling specific bottles of Endocet 10 mg/650 mg tablets because some contained mixed 10 mg/325 mg tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves a mix-up of two different strengths of the same medication, which is a labeling/quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling 11,764 bottles of Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count. The recall is due to a customer complaint that some bottles contained Endocet 10 mg/325 mg tablets mixed with the 10 mg/650 mg tablets.
The affected product is identified by Lot # 402794NV with an expiration date of 12/13. The NDC number is 60951-797-70. The product was distributed nationwide and in Puerto Rico.
Consumers should check their medication for this specific lot number and expiration date. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,764
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 402794NV
- Exp 12/13
Distribution
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