The Recall Desk

FDA (Drugs) recall action 72476

Par Pharmaceutical Inc. recalled 2 products on 2015-11-25

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
2015-11-25
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation Specifications: Out of specification for impurities.

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

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

    Product
    Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Distribution
    1 state