D-0963-2018 Class II Terminated
FDA drug recall D-0963-2018 was initiated by Avella Of Deer Valley, Inc. Store 38 on Jun 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 Jan 24, 2020). Affected quantity: 10500 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 12, 2018
- Termination Date
- Jan 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10500 syringes
Product Description
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0963-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026