Ampicillin Injectable Solution Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution due to lack of sterility assurance. The affected product was dispensed nationwide; patients should contact their healthcare provider.
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: This is an FDA Class II recall of an injectable medication with potential sterility failure, which poses a risk of infection from non-sterile administration. Although no illnesses or injuries have been reported in the source material, the theoretical hazard associated with loss of sterility assurance in injectable drugs justifies a High severity rating.
Plain-English summary
Sentara Infusion Services is recalling Ampicillin 12GM in NS 600M injectable solution (19 bags) due to lack of sterility assurance. The product is used with a Curlin pump for intravenous administration.
The recall affects patients nationwide who received this medication. The affected product has a beyond-use date of December 25–29, 2022.
Patients who received this product should contact their healthcare provider or pharmacist immediately to discuss the recall and any potential next steps. Healthcare providers should not dispense any remaining affected product.
The recalled product
- Product
- AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 19
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 (2)
- Beyond Use date: December 25 - December 29
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services 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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