FDAFDA · Food and drugs·Recall number D-0487-2019
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Published February 20, 2019 · Recall initiated: January 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARDIZEM CD
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0301870796421
- Lot
- Lots: a) 18J023P, Exp 08/2020; b) 18J021P, Exp 08/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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