FDAClass IIApril 19, 2023

Pantoprazole Sodium Delayed Release Tablets USP 40mg recall: CGMP Deviations

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ…

Why was Pantoprazole Sodium Delayed Release Tablets USP 40mg recalled?

CGMP Deviations: Discoloration

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: PAN22542, Exp. Date: 9/2024

Product
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ…
Recalling firm
Hetero USA Inc
Quantity
2,352 bottles
Distribution
Nationwide within the United States
Recall date
April 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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