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Recall Observatory FDA recall evidence

Drug 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

D-0145-2020

September 04, 2019

Class II

Product summary

Firm
Jubilant Cadista Pharmaceuticals, Inc.
Event
Event 83705
Status
Terminated
Classification
Class II
Quantity
63,216 bottles
Official record key
drug-enforcement:D-0145-2020

Official wording

Reason: CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Code information: Lot # PA218P008, PA218P009, Exp 04/2021

Distribution pattern: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation