Ampicillin for Injection Recalled for Lack of Sterility Assurance
Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 injectable medication for which sterility cannot be assured. No illnesses or injuries have been reported. The theoretical risk posed by potential contamination in an injectable product warrants a High severity rating.
Plain-English summary
Piramal Critical Care is recalling Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package (NDC 66794-224-15), manufactured by Astral SteriTech Private Ltd. All lots within their expiry dates are included in this nationwide recall.
The manufacturer cannot assure the sterility of the product. If the product is contaminated, patients who receive the medication could be at risk for serious infections.
Approximately 8,925 bottles have been distributed nationwide within the United States.
Patients who have received this product should contact their healthcare provider or pharmacist immediately. Healthcare facilities should quarantine the affected product and return it to the supplier.
The recalled product
- Product
- Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Hazard
- Affected units
- 8,925
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.
See all 52 products in this recall →Related recalls
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