Valeant Pharmaceuticals North America LLC recalls Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division o…
- Recall date
- January 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0491-2019
- FDA classification
- Class III
- Brand / firm
- Valeant Pharmaceuticals North America LLC
- Sold / distributed
- Nationwide in the USA and Puerto Rico
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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