Home / Recalls / Avella of Deer Valley, Inc. Store 38 / D-0224-2019

D-0224-2019 Class II Terminated

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

FDA drug recall D-0224-2019 was initiated by Avella of Deer Valley, Inc. Store 38 on October 31, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated January 18, 2019). Affected quantity: 911 syringes.

Recall Details

Product Type: Drugs
Report Date: November 14, 2018
Initiation Date: October 31, 2018
Termination Date: January 18, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 911 syringes

Product Description

BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Product was distributed throughout the United States.

Code Information

Lot # 138-20182408@58 BUD 12/22/2018

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-0997-2019 Class II — Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single (February 8, 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-0998-2019 Class II — MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 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-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-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)
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-0133-2019 Class II — Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a (October 19, 2018)