The Recall Desk

FDA (Drugs) recall action 76819

Sun Pharmaceutical Industries, Inc. recalled 4 products on 2017-05-17

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-05-17
Critical
0
Units
59,298

Why these products were recalled

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.

    Product
    Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceut
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Distribution
    1 state