FDAClass IIISeptember 28, 2016

Lisinopril Tablets USP recall: CGMP Deviations

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States…

Why was Lisinopril Tablets USP recalled?

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

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?

Batch number: H303449, Exp 09/16

Product
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
5,880 bottles
Distribution
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Recall date
September 28, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls