The Recall Desk

FDA (Drugs) recall action 76539

Dr. Reddy's Laboratories, Inc. recalled 4 products on 2017-03-08

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
2017-03-08
Critical
0
Units
24,582

Why these products were recalled

Failed dissolution specifications - low dissolution results at S3 stage.

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.

1–4 of 4

  • ModerateFDA (Drugs)··2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 30 mg capsules because they failed to meet dissolution specifications.

    Product
    Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The affected lot is distributed nationwide.

    Product
    ZENATANE (ISOTRETINOIN)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The recall covers 4,404 cartons distributed nationwide.

    Product
    ZENATANE (ISOTRETINOIN)
    Category
    Distribution
    0 states