Alvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure
Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg because the lot failed uniformity of dosage units specifications for the oxycodone component.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality control failure rather than a high-risk pathogen or structural defect.
Plain-English summary
Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg (100 count). The product is distributed nationwide. The specific lot affected is #453289 with an expiration date of 08/31/15 and NDC #47781-0230-01. The tablets were manufactured by Norwich Pharmaceuticals Inc. and distributed by Alvogen, Inc.
The recall was initiated because the lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component. This means the amount of oxycodone in individual tablets may vary more than allowed by specifications.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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.
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Prescription Medication
- Hazard
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 (3)
- NDC #47781-0230-01
- Lot # 453289
- Exp 08/31/15
Distribution
Distributed nationwide across the United States.
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