Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Reported: May 8, 2013 Initiated: February 11, 2013 #D-296-2013
Product Description
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Reason for Recall
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals Inc.
- Units Affected
- 12770 bottles
- Distribution
- Nationwide
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90. Recalled by Jubilant Cadista Pharmaceuticals Inc.. Units affected: 12770 bottles.
Why was this product recalled? ▼
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2013. Severity: Moderate. Recall number: D-296-2013.
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