FDAClass IINovember 20, 2019

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules recall: Nitrosamine Impurity

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC…

Why was Novitium Pharma Ranitidine Capsules 150 mg 60 capsules 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?

all lots within expiry.

Product
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC…
Recalling firm
Novitium Pharma LLC
Quantity
19560 bottles
Distribution
Nationwide
Recall date
November 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls