Reported Mar 8, 2023 · Terminated

Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc.,…

Accord Healthcare, Inc.

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: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

  • Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton
  • Manufactured forAccord Healthcare, Inc., Durham
  • NC 27703 Manufactured by
    • Intas Pharmaceuticals Limited
    • Pharmez
    • Ahmedabad-382 213
    • INDIA. Packet NDC 16729-521-63
    • UPC 3 16729 52163 5
    • Carton NDC 16729-521-11
    • UPC 3 16729 52111 6
Lot codes and dates
  • Batches
    • R2100308
    • Exp. Date 2/28/2023
Amount recalled
821 cartons

This recall covers 67 products

The agency filed one notice per product. You are reading one of them; the other 66 are below.

54 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.