Pantoprazole Sodium for Injection Recalled Due to Sterility Concern
BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection nationwide due to lack of sterility assurance caused by powder discoloration and small cracks in some vials. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of injectable medication with a theoretical sterility contamination risk due to vial cracks. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection 40mg across the United States. The recall affects approximately 41,148 vials distributed nationwide, including single-dose vials packaged in boxes of 10 or 25 units, with multiple lot numbers and expiration dates through February 2025.
The FDA classified this recall as Class II due to a lack of assurance of sterility in some vials. The issue results from powder discoloration caused by small cracks in certain vials, which could potentially allow microbial contamination.
Patients who have received this medication should contact their healthcare provider if they have concerns. Healthcare facilities in possession of affected vials should quarantine them and contact BE Pharmaceuticals regarding return procedures.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- BE PHARMACEUTICALS AG
- Hazard
- sterility-concern
- contamination-risk
- crack-in-vial
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: (a) GSC04002A
- GSC04003A
- GSC04004A
- GSC04006A
- Exp Mar-2024
- GSC05001A
- GSC05006A
- GSC05007A
- Exp April-2024
- GSC10003A
- GSC10005A Exp Sep-2024
- GSC06004A
- GSC06005A
- Exp May-2024
- GSC07001A
- GSC07007A
- GSC07008A
- GSC07009A
- Exp Jun-2024
- GSC08001A
UPCs (1)
- 0371839122011
Distribution
Distributed nationwide across the United States.
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