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.

FDA recall notice · announced October 17, 2018 · Jubilant Cadista Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Notes

Distribution: Product was distributed Nationwide in the USA and Puerto Rico.
Lot/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.
Quantity: 158,466 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0011-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.