Home / Recalls / Avella of Deer Valley, Inc. Store 38 / D-0956-2018

D-0956-2018 Class II Terminated

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

FDA drug recall D-0956-2018 was initiated by Avella of Deer Valley, Inc. Store 38 on June 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 January 24, 2020). Affected quantity: 220 bags.

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
220 bags

Product Description

Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10

Reason for Recall

Lack of Assurance of Sterility: Potential leakage of bags.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #:5/21/18 0506 240-40810P, BUD 8/4/2018; 5/22/18 0501 86-40810P, BUD 8/5/2018; 5/25/18 0900 410-40810P, BUD 8/8/2018; 6/6/18 0836 86-40810P, BUD 8/20/2018.

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-1000-2019 Class II — MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compou (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-0135-2019 Class II — Phenylephrine 30 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)
  • 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)

FDA data resources