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Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68...

FDA Recall #D-0513-2019 — Class III — February 13, 2019

Recall #D-0513-2019 Date: February 13, 2019 Classification: Class III Status: Terminated

Product Description

Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.

Reason for Recall

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

44,640 bottles

Distribution

Nationwide in the USA and Puerto Rico.

Code Information

Lot #: a) G702755, Exp March 2020; b) G702756, Exp March 2020

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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