Pantoprazole Sodium Delayed Release Tablets recall: CGMP Deviations
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Why was Pantoprazole Sodium Delayed Release Tablets recalled?
CGMP Deviation: 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 # PA218P008, PA218P009, Exp 04/2021
- Product
- Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Quantity
- 63,216 bottles
- Distribution
- Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)