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.
Reported: October 1, 2014 Initiated: August 28, 2014 #D-1607-2014
Product Description
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 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.
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 8,964 (100 Count) bottles
- Distribution
- Nationwide
- Location
- Pine Brook, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Alvogen, Inc. Units affected: 8,964 (100 Count) bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2014. Severity: Moderate. Recall number: D-1607-2014.
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