Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specification; 9 month stability
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
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 Sub-potent Drug: Lower potency than labeled.
Reason Impurity failure at 0-time of the repackaged lot.
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