FDAClass IIJanuary 8, 2014

Fosinopril Sodium and Hydrochlorothiazide Tablets recall: Subpotent

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

Why was Fosinopril Sodium and Hydrochlorothiazide Tablets recalled?

Subpotent; Hydrochlorothiazide at the 9 month time point.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot CU0856

Product
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Recalling firm
Sandoz Inc
Quantity
2,491 bottles of 100 tablets each
Distribution
Nationwide
Recall date
January 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls