Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Sub-potent Drug: Lower potency than labeled.
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Impurity failure at 0-time of the repackaged lot.
Reason Out-of-specification impurity test result observed at 18-month long term stability time point.
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