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Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceutical...

FDA Recall #D-1077-2018 — Class II — August 13, 2018

Recall #D-1077-2018 Date: August 13, 2018 Classification: Class II Status: Terminated

Product Description

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

Reason for Recall

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

11,706 bottles

Distribution

Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.

Code Information

Lot #: H800414, Exp. 12/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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