FDA recall D-0489-2019

Product

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.

Reason for recall

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-01-30

Report date

2019-02-20

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2019