FDAClass IINovember 20, 2019

Equate Maximum Strength Ranitidine Tablets recall: Nitrosamine Impurity

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00

Why was Equate Maximum Strength Ranitidine Tablets recalled?

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

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?

All lots remaining within expiry.

Product
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
Recalling firm
Apotex Inc.
Quantity
1,132,453 bottles
Distribution
Nationwide
Recall date
November 20, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls