FDA Drug recall D-0139-2018
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/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 HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/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-0139-2018 |
| 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
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
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: 170615-004, 9/13/2017; 170720-009, 10/18/2017 |
|---|
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-0139-2018%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.