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 April 10, 2019 · Jubilant Cadista Pharmaceuticals

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

The product

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: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: PA217060A, Exp 05/2020
Quantity: 12,960 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-1074-2019)

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