Class II · Moderate risk Ongoing
Pantoprazole Sodium
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Pantoprazole Sodium Delayed-Release Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
What was recalled
Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90
- Recalling firm
- Aurobindo Pharma USA Inc
- NDC code
- 65862-0560-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1499-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pantoprazole recalls
See all
Class II · Moderate risk Terminated
Pantoprazole Sodium for Injection 40mg per vial
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk Completed
Pantoprazole sodium for Injection 40 mg*/vial
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk Ongoing
Pantoprazole Sodium Delayed Release Tablets USP 40mg
Reason CGMP Deviations: Discoloration
Class II · Moderate risk Terminated
Pantoprazole 30mg in Ns 7.5ml
Reason Lack of sterility assurance
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