FDA Drug recall D-1607-2014
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only
- FDA Drug
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only by Alvogen, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1607-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-28 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alvogen |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | NDC #47781-0230-01; Lot # 453289; Exp 08/31/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1607-2014%22
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