Class II
Terminated
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.
This recall has been terminated (originally issued October 1, 2014).
- Company
- Alvogen, Inc
- Recall Initiated
- August 28, 2014
- Posted
- October 1, 2014
- Recall Number
- D-1607-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,964 (100 Count) bottles
- Firm Location
- Pine Brook, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
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