Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottl…
- Recall date
- January 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0489-2019
- 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
Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
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