Tobramycin 120MG recalled over sterility concerns
- Recall date
- September 18, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Sentara Enterprises recalls Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300,…
- Recall number
- D-0642-2016
- FDA classification
- Class II
- Brand / firm
- Sentara Enterprises
- Sold / distributed
- U.S. Including: VA, NC
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
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