Drug Enforcement D-383-2014

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

Status

Terminated

Classification

Class II

Report Date

January 1, 2014

Termination Date

July 10, 2014

Product Information

Product description
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
Product quantity
12,521 bottles
Reason for recall
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Sandoz Incorporated
Address
2555 W Midway Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-383-2014
Event ID
66531
Recall initiation date
October 22, 2013
Center classification date
December 20, 2013
Code info
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
More code info
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