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Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Ge...

FDA Recall #D-0576-2020 — Class II — December 2, 2019

Recall #D-0576-2020 Date: December 2, 2019 Classification: Class II Status: Terminated

Product Description

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.

Reason for Recall

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

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

1,824 bottles

Distribution

Nationwide in the USA.

Code Information

Lot #: NT119005A, Exp 07/2021

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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