FDA recall D-383-2014

Product

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

Reason for recall

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-10-22

Report date

2014-01-01

Termination date

2014-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-383-2014