FDAClass IINovember 20, 2019

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets recall: Nitrosamine Impurity

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

Why was Rite Aid Pharmacy 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
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
Recalling firm
Apotex Inc.
Quantity
215,387 bottles
Distribution
Nationwide
Recall date
November 20, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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