Drug product
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
D-0964-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 syringes
- Official record key
drug-enforcement:D-0964-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot #: 5/10/18 1451 89561S, BUD 9/7/2018 .
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility