FDAFDA · Food and drugs·Recall number D-0491-2019
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 68682-521-01.
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
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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