FDA Drug recall D-1218-2014
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 8…
- FDA Drug
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 8… by Zions Rx Formulations Services, citing lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1218-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-12 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zions Rx Formulations Services |
| Distribution | AZ |
Product
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Reason
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Identifiers
| code_info | Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013 |
|---|
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-1218-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.