FDA Drug recall D-0943-2018
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe
- FDA Drug
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0943-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-12 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avella Of Deer Valley Store 38 |
| Distribution | US |
Product
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Identifiers
| code_info | Lot #: 05/10/18 2011 89161S, BUD 9/7/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0943-2018%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.