The Recall Desk

FDA (Drugs) recall action 82021

Valeant Pharmaceuticals North America LLC recalled 5 products on 2019-02-20

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2019-02-20
Critical
0
Units
25,525

Why these products were recalled

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

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

1–5 of 5

  • LowFDA (Drugs)··2019-02-20

    Valeant Recalls Diltiazem HCl Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.

    Product
    Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 390 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 1,023 bottles of Cardizem CD (diltiazem hydrochloride) 120 mg capsules because they failed to meet dissolution specifications.

    Product
    CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 22 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.

    Product
    CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Distribution
    1 state