Apotex Corp. Recall: Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bott
Apotex Corp. Recall: Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bott is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Apotex Corp.; Product: Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-
| Recalling firm | Apotex Corp. |
|---|---|
| Product | Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. |
| Reason for recall | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide |
| Recall initiated | 20231101 |
| Recall number | D-0121-2024 |
| Category | drug |
| State | FL |
| Country | United States |
$29/mo
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