FDAJanuary 30, 2019drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
valeant pharmaceuticals north americavaleantvaleant pharmaceuticals
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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