The Recall Desk

FDA (Drugs) recall action 76982

Jubilant Cadista Pharmaceuticals, Inc. recalled 3 products on 2017-04-19

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-04-19
Critical
0
Units
121,641

Why these products were recalled

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

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.

1–3 of 3

  • LowFDA (Drugs)··2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Failure

    Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets Due to Impurities

    Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because they failed impurity specifications.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-04-19

    Jubilant Cadista Recalls Bupropion Hydrochloride Tablets for Impurity Issues

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.

    Product
    BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmace
    Category
    Distribution
    0 states