The Recall Desk

FDA (Drugs) recall action 77605

Shionogi Inc. recalled 2 products on 2017-07-26

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
2017-07-26
Critical
0
Units
6,759

Why these products were recalled

Failed Dissolution Specifications: Low dissolution results were obtained during stability testing

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.

1–2 of 2

  • LowFDA (Drugs)··2017-07-26

    Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures

    Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.

    Product
    Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2017-07-26

    Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications

    Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.

    Product
    PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
    Category
    Distribution
    0 states