Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Pantoprazole 30mg in Ns 7.5ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Drug: Pantoprazole Category: Heartburn & Stomach Medication
- Recalling firm
- Sentara Infusion Services
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0313-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pantoprazole recalls
See all
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
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
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Other recalls by Sentara Infusion Services
All 2022 recalls
Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
Vancomycin
Lack of sterility assurance
Class II · Moderate risk
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM…
Lack of sterility assurance
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