The Recall Desk

FDA (Drugs) recall action 84570

Sun Pharmaceutical Industries, Inc. recalled 2 products on 2020-01-22

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-01-22
Critical
0
Units
207,585

Why these products were recalled

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Drugs)··2020-01-22

    Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

    Product
    Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
    Category
    Distribution
    0 states