Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Reported: March 25, 2020 Initiated: March 11, 2020 #D-1058-2020
Product Description
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Reason for Recall
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 89,376 90-count bottles
- Distribution
- Distributed 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, NDC 59746-284-90. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 89,376 90-count bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 25, 2020. Severity: Moderate. Recall number: D-1058-2020.
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