Reported Dec 6, 2023 · Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#:…
Apotex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
Paroxetine Hydrochloride Tablets USPRX only10 mg a) 30-count bottleNDC#: 60505-0097-1b) 100-count bottleNDC#: 60505-0097-2c) 1000-count bottleNDC#: 60505-0097-4
- Manufactured byApotex Inc., Toronto, Ontario, Canada M9L 1T9
- Manufactured forApotex Corp., Weston, Florida 33326
- Lot codes and dates
- Lot numbersa)100
- count bottle
RV2376RV2377
- b) 1000 count bottle
RV2379RV2380
- c) 30 count bottle
RV2375Exp. 08/2024
- Amount recalled
- 34,392
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
This product could cause temporary or reversible health problems — stop using it.
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