Levaquin 750MG Injectable Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.
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 injuries have been reported. Classified as High due to risk-of-harm from non-sterile injectable medication without reported injury.
Plain-English summary
Sentara Infusion Services is recalling 14 bags of Levaquin 750MG IN D5W, an injectable antibiotic medication, because the product may lack adequate sterility assurance. This injectable formulation is designed to be administered to patients via home infusion pump.
The affected product was dispensed nationwide to patients. Based on the Beyond Use Date of December 24-31, 2022, the recalled bags may still be in use.
Patients who received this product should contact their healthcare provider or Sentara Home Infusion Pharmacy Services (535 Independence Parkway, Suite 300, Chesapeake, VA 23320) immediately. Do not use the product if you still have it; return unused portions to your pharmacy or physician.
The recalled product
- Product
- Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Affected units
- 14
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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