Drug Enforcement D-393-2014

Subpotent; Hydrochlorothiazide at the 9 month time point.

Status

Terminated

Classification

Class II

Report Date

January 8, 2014

Termination Date

March 5, 2015

Product Information

Product description
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Product quantity
2,491 bottles of 100 tablets each
Reason for recall
Subpotent; Hydrochlorothiazide at the 9 month time point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Sandoz Inc
Address
4700 Sandoz Dr

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

Codes & Dates

Recall number
D-393-2014
Event ID
66554
Recall initiation date
October 11, 2013
Center classification date
December 30, 2013
Code info
Lot CU0856
More code info
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