Glenmark Pharmaceuticals Inc., USA 2024-06-12 Health serious FDA
Health · FDA · Recall #FDA-D-0532-2024
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:… Recall
Issued June 12, 2024 · Glenmark Pharmaceuticals Inc., USA
In June 2024, Glenmark Pharmaceuticals Inc., USA recalled the Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
What you should do
- 1 Stop using Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Glenmark Pharmaceuticals Inc., USA 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
- Glenmark Pharmaceuticals Inc., USA
- Category
- Health
- Recall date
- June 12, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0532-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Glenmark Pharmaceuticals Inc., USA has 53 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.