Apotex Corp. 2023-12-06 Health serious FDA
Health · FDA · Recall #FDA-D-0120-2024
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle,… Recall
Issued December 6, 2023 · Apotex Corp.
In December 2023, Apotex Corp. recalled the Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
What you should do
- 1 Stop using Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Apotex Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Apotex Corp.
- Category
- Health
- Recall date
- December 6, 2023
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0120-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Apotex Corp. has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.