FDAClass IIJanuary 29, 2020

Preferred Pharmaceuticals recall: Nitrosamine Impurity

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3)…

Why was Preferred Pharmaceuticals recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

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 #: All lots within expiry

Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3)…
Recalling firm
Preferred Pharmaceuticals, Inc
Quantity
39,172 tablets
Distribution
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Recall date
January 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls