Recalls / Class III
Class IIID-0488-2019
Product
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
- Brand name
- Cardizem Cd
- Generic name
- Diltiazem Hydrochloride
- Active ingredient
- Diltiazem Hydrochloride
- Route
- Oral
- NDCs
- 0187-0795, 0187-0796, 0187-0797, 0187-0798, 0187-0799
- FDA application
- NDA020062
- Affected lot / code info
- Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020
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.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Manufacturer
- Bausch Health US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 206 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-01-30
- FDA classified
- 2019-02-14
- Posted by FDA
- 2019-02-20
- Terminated
- 2020-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0488-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.