Class II recall: Apotex Corp.: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only
Apotex Corp. issued a Class II recall for Paxil CR (paroxetine extended-release tablets), 37.5mg, 30-count bottles, NDC 60505-4379-3. According to the FDA recall notice, the product failed to meet 24-month stability testing acceptance criteria due to failed dissolution specifications.
Most relevant for: Patients prescribed paroxetine extended-release 37.5mg tablets from the affected lot for depression or other approved indications.
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