D-0930-2018 Class II Terminated
FDA drug recall D-0930-2018 was initiated by Avella of Deer Valley, Inc. Store 38 on June 12, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential leakage of bags. The recall status is terminated (terminated January 24, 2020). Affected quantity: 5400 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2018
- Initiation Date
- June 12, 2018
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5400 syringes
Product Description
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 for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
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;