Penicillin Intravenous Antibiotic Recalled Over Lack of Sterility Assurance
Sentara Infusion Services is recalling eight bags of intravenous penicillin antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide.
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 for injectable antibiotic with lack of sterility assurance. No illnesses or hospitalizations reported. This is a risk-of-harm product where potential injury has not yet been reported, meeting the High severity threshold.
Plain-English summary
Sentara Infusion Services is recalling eight bags of penicillin intravenous antibiotic due to lack of sterility assurance. The recalled product consists of three formulations: 40MU in 5% dextrose (D5W) 400ML for continuous infusion, 40U in D5W 400ML for continuous infusion, and 48MU in D5W 480ML. All affected bags have a beyond-use date of December 25-31, 2022.
The recalled medication was dispensed to patients nationwide. Patients who received this antibiotic should contact their healthcare provider about this recall.
The recalled product
- Product
- PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use 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
- Hazard
- Affected units
- 8
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 25-31
- 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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