Meropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling 91 bags of meropenem injectable antibiotic due to lack of sterility assurance. The product was dispensed nationwide to patients.
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 an injectable antibiotic lacking sterility assurance. No illnesses or injuries reported. Classified as high-risk due to the potential for serious infection if patients receive non-sterile medication.
Plain-English summary
Sentara Infusion Services is recalling 91 bags of meropenem antibiotic injectable solution due to lack of sterility assurance. The affected product includes three concentrations: 1000 mg in 250 mL, 2 gm in 100 mL, and 500 mg in 125 mL. The product is available by prescription only and is designed for use with or without a home infusion pump.
The recall is due to lack of sterility assurance in the preparation of the product. If meropenem is not sterile, patients could be exposed to microbial contamination.
The affected product was distributed nationwide and dispensed directly to patients. The beyond-use date for the affected product was December 24-31, 2022.
Patients who received this product should not use it. Contact your healthcare provider or pharmacy immediately to return the product.
The recalled product
- Product
- MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Affected units
- 91
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 24-31
- 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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