Home / Recalls / Avella of Deer Valley, Inc. Store 38 / D-0930-2018

D-0930-2018 Class II Terminated

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

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;

Other recalls by Avella of Deer Valley, Inc. Store 38

D-0152-2020 Class II — Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Av (September 18, 2019)
D-1308-2019 Class II — Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPEC (May 3, 2019)
D-0999-2019 Class II — MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag (February 8, 2019)
D-1000-2019 Class II — MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compou (February 8, 2019)
D-0997-2019 Class II — Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single (February 8, 2019)
D-0998-2019 Class II — MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, (February 8, 2019)
D-0224-2019 Class II — BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in norm (October 31, 2018)
D-0132-2019 Class II — Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, I (October 19, 2018)
D-0134-2019 Class II — Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a (October 19, 2018)
D-0131-2019 Class II — Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella (October 19, 2018)