Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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 23, 2019 Initiated: September 4, 2019 #D-0145-2020
Product Description
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 63,216 bottles
- Distribution
- Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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: 63,216 bottles.
Why was this product recalled? ▼
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2019. Severity: Moderate. Recall number: D-0145-2020.
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