FDA Drug recall D-0930-2018
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe
- FDA Drug
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use 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-0930-2018 |
| 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 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Identifiers
| code_info | Lot # 3/5/18 8055 80561S, 3/5/18 0514 80561S, 3/5/18 5259 80561S, 3/5/18 6131 80561S, 3/5/18 5641 80561S, BUD 7/3/201…Lot # 3/5/18 8055 80561S, 3/5/18 0514 80561S, 3/5/18 5259 80561S, 3/5/18 6131 80561S, 3/5/18 5641 80561S, BUD 7/3/2018; 5/10/18 1312 80561S, 5/10/18 1322 80561S, 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-0930-2018%22
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