FDA Drug recall D-0143-2018
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug
- FDA Drug
- Class II
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug by Ssm Health Care St Louis, citing lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0143-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-10 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ssm Health Care St Louis |
| Distribution | MO |
Product
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
Reason
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Identifiers
| code_info | Lot, exp: 170619-011, 9/17/2017; 170707-007, 10/5/2017; 170713-009, 10/11/2017 |
|---|
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-0143-2018%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.