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: October 17, 2018 Initiated: October 2, 2018 #D-0011-2019
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: Presence of dark discoloration or brown spots on the edges of the tablets.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 158,466 bottles
- Distribution
- Product was distributed Nationwide in the USA and Puerto Rico.
- 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: 158,466 bottles.
Why was this product recalled? ▼
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 17, 2018. Severity: Moderate. Recall number: D-0011-2019.
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