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.
Reported: April 10, 2019 Initiated: March 29, 2019 #D-1074-2019
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: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 12,960 bottles
- Distribution
- Nationwide in the USA.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 12,960 bottles.
Why was this product recalled? ▼
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2019. Severity: Moderate. Recall number: D-1074-2019.
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