FDA Drug recall D-0632-2016
PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2016-02-03
On 2016-02-03 the FDA classified a Class II recall of PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only 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-0632-2016 |
| 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
PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML 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) 27-Sep-15, b) 28-Sep-15, 30-Sep-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-0632-2016%22
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