Ampicillin and Sulbactam Injection Recalled for Sterility Assurance Failure
Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. 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: FDA Class II recall of an injectable pharmaceutical with failed sterility assurance carries risk of serious infection. However, no illnesses or injuries have been reported in the source, and the hazard remains theoretical. Per the rubric, unconfirmed theoretical hazards without reported adverse events score at most 3 (High).
Plain-English summary
Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection, USP, 15 grams per Pharmacy Bulk Package (NDC 71288-007-75) manufactured by Astral SteriTech Private Ltd. Approximately 35,087 bottles were distributed nationwide within the United States. All affected lots remain within their expiration date.
The product is being recalled because manufacturers were unable to assure the sterility of the product. Injectable medications must be sterile to prevent serious infections in patients. When sterility cannot be assured, there is risk of microbial contamination.
Healthcare facilities, pharmacies, and hospitals that received this product should stop distribution and dispensing immediately. If you received a dose from this product, contact your healthcare provider or pharmacy. Unused portions should be returned to the distributor or disposed of according to institutional guidelines.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Hazard
- contamination
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.
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