D-0011-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 17, 2018
- Initiation Date
- October 2, 2018
- Termination Date
- February 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158,466 bottles
Product Description
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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.
Reason for Recall
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Distribution Pattern
Product was distributed Nationwide in the USA and Puerto Rico.
Code Information
Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.