Class II
Terminated
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
- Recall Initiated
- September 4, 2019
- Posted
- October 23, 2019
- Recall Number
- D-0145-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 63,216 bottles
- Firm Location
- Salisbury, MD, United States
Reason for Recall
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
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.
Lot / Code Info
Lot # PA218P008, PA218P009, Exp 04/2021
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