FDA-Drug2014-01-01Class II

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

Sandoz Incorporated
Hazard

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

Sold states
Nationwide
Affected count
12,521 bottles
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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

Official notice

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

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