Reported Feb 20, 2019 · Terminated
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count…
Valeant Pharmaceuticals North America LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
- Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only
- Manufactured forValeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
- ByValeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada
- Lot codes and dates
- Lots
a) 18J018PExp 08/2020b) 18J029PExp 08/2020
- Lots
- Amount recalled
- 206 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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