FDAClass IIDecember 18, 2019

Amantadine Hydrochloride Tablets recall: Foreign Material

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by…

Why was Amantadine Hydrochloride Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: NT119005A, Exp 07/2021

Product
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by…
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
1,824 bottles
Distribution
Nationwide in the USA.
Recall date
December 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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