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Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards o...

FDA Recall #D-0861-2022 — Class II — April 1, 2022

Recall #D-0861-2022 Date: April 1, 2022 Classification: Class II Status: Terminated

Product Description

Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16

Reason for Recall

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Recalling Firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) — Rockford, IL

Classification

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

Product Type

Drugs

Product Quantity

885 cartons

Distribution

Nationwide within USA

Code Information

Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022

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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