FDA Drug recall D-1553-2014
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional o…
- FDA Drug
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional o… by Healix Infusion Therapy, citing lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1553-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-27 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Healix Infusion Therapy |
| Distribution | GA, TX |
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
Reason
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Identifiers
| code_info | Lot 7250-0 Exp. 08/14 |
|---|
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-1553-2014%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.