FDA Recalls Ampicillin and Sulbactam Injectable Over Sterility Defect
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
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: FDA Class II recall affecting an injectable medication with documented lack of sterility assurance. While no illnesses have been reported, this manufacturing defect poses an inherent risk of harm to patients, meeting criteria for Score 3 under the risk-of-harm category.
Plain-English summary
Ampicillin and Sulbactam for Injection, USP 3 grams per vial is being recalled. The medication was manufactured by Astral SteriTech Private Ltd. for Meitheal Pharmaceuticals and distributed nationwide within the United States.
The FDA issued this Class II recall due to lack of assurance of sterility affecting approximately 1,229,090 vials. All lots currently within their expiration date are included in the recall.
Patients who have received this injectable medication and healthcare facilities with remaining stock should contact their healthcare provider or the FDA for guidance on appropriate action.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 1,229,090
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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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