Drug 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
D-0930-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5400 syringes
- Official record key
drug-enforcement:D-0930-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: 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;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility