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Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured b...

FDA Recall #D-1058-2020 — Class II — March 11, 2020

Recall #D-1058-2020 Date: March 11, 2020 Classification: Class II Status: Terminated

Product Description

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

Reason for Recall

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

Recalling Firm

Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Classification

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

Product Type

Drugs

Product Quantity

89,376 90-count bottles

Distribution

Distributed Nationwide in the USA

Code Information

Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021

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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