The Recall Desk

FDA (Drugs) recall action 79446

InvaGen Pharmaceuticals, Inc. recalled 2 products on 2018-04-11

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
2018-04-11
Critical
0
Units
—

Why these products were recalled

Failed Dissolution Specifications; during stability testing

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

1–2 of 2

  • ModerateFDA (Drugs)··2018-04-11

    InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-04-11

    InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
    Category
    Distribution
    0 states