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Drug FDA Class II Ongoing cGMP deviation

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

Glenmark Pharmaceuticals Inc., USA Published Jun 12, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Hazards

N-Nitroso Desmethyl Rizatriptan · primary

Affected products (1)

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

RIZATRIPTAN BENZOATE · 3,480 cartons

NDC: 68462-465, 68462-466, 68462-465-72, 68462-465-99, 68462-466-72, 68462-466-99
Code info: Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    May 10, 2024
  2. Published
    Jun 12, 2024
Recall number
D-0532-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.