FDA Drug recall D-0623-2016
VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepum…
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepum… by Sentara Enterprises, citing lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0623-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-18 |
| Published | 2016-02-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sentara Enterprises |
| Distribution | NC, VA |
Product
VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Identifiers
| code_info | All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-…All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-Sep-15 d) 25-Sep-15, 26-Sep-15, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0623-2016%22
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