D-0960-2018 Class II Terminated

Recalled by Avella Of Deer Valley, Inc. Store 38 — Phoenix, AZ

FDA drug recall D-0960-2018 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: 2280 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
2280 bags

Product Description

NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 4/30/18 2471 80725P, BUD 6/29/2018; 5/1/18 1240 80725P, BUD 6/30/2018; 5/8/18 1111 80725P 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-0960-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.