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Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured...

FDA Recall #D-0129-2019 — Class II — October 19, 2018

Recall #D-0129-2019 Date: October 19, 2018 Classification: Class II Status: Terminated

Product Description

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

Reason for Recall

Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.

Recalling Firm

Teva Pharmaceuticals USA — North Wales, PA

Classification

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

Product Type

Drugs

Product Quantity

53,451 bottles

Distribution

U.S.A. Nationwide including Puerto Rico.

Code Information

Lot # 1220211M, Exp 02/2019

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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