D-0939-2018 Class II Terminated
FDA drug recall D-0939-2018 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: 4,280 bags.
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
- 4,280 bags
Product Description
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0939-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026