Pantoprazole Sodium Delayed-Release Tablets recall: CGMP Deviations
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC…
Why was Pantoprazole Sodium Delayed-Release Tablets recalled?
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
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 # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
- Product
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC…
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Quantity
- 89,376 90-count bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)