Sentara Recalls Tobramycin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Tobramycin 120MG Homepumps because the sterility of the product cannot be guaranteed. The affected lots were compounded in September 2015.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a lack of assurance of sterility in a medical product, which carries a risk of serious health consequences.
Plain-English summary
Sentara Enterprises is recalling Tobramycin 120MG, packaged in 150ML Homepumps, which are prescription-only products. The recall is being conducted because the company cannot guarantee the sterility of the product.
The affected product consists of 1 Bag units. All lots compounded between September 11, 2015, and September 17, 2015, are included in this recall, with an expiration date of September 29, 2015. The product was distributed in the United States, specifically in Virginia and North Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the medication.
The recalled product
- Product
- Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
- Affected units
- 1
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 compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises 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 34 products in this recall →Related recalls
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