CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report

MAGnesium 4gm in NS (MAGnesium SULfate (USP) 4 gm recalled

Avella of Deer Valley Inc. Store 38 is recalling MAGnesium 4gm in NS (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP), distributed nationwide in the US. The recall was initiated on 12 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 5/1/18 0501 548-90510P, BUD 7/30/2018.
Quantity recalled100 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0936-2018
FDA event ID
80307
Recalling firm
Avella of Deer Valley Inc. Store 38, Phoenix, AZ
Classification
Class II
Status
Terminated
Recall initiated
12 Jun 2018
FDA classified
19 Jul 2018
Reported
25 Jul 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

12 Jun 2018Recall initiated by company
19 Jul 2018Classified by FDA+37 days
25 Jul 2018Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: Potential leakage of bags.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

Which lots are affected?

Lot # 5/1/18 0501 548-90510P, BUD 7/30/2018.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

37 other products · FDA event 80307

This product is part of a recall event; the main page for the event is 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg recalled.

ReportedClassRecallCompanyReasonWhere
CLASS II0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIfentaNYL (10 mcg per mL) in 0.95 Sodium Chloride recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMidazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIceFAZolin 2 gm in NS ceFAZolin Sodium (USP) 2gm recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIePHEDrine Sulfate, USP 50mg recalled by Avella of Deer Valley, Inc.Avella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIPHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IINORepiNEPHrine 8 mg (norepinephrine Bitartrate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IINORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHeparin in 5% Dextrose (Heparin Sodium recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMORphine 150 mg (Morphine Sulfate, USP 150mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHeparin in 5% Dextrose recalled by Avella of Deer Valley, Inc.Avella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMAGnesium 1gm in NS (MAGnesium SULfate (USP) 1 gm recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMidazolam 1 mg/mL (Midazolam HCL (USP) 100 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIPHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IINORepiNEPHrine4mg (Norepinephrine Bitartrate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMAGnesium 2gm in NS (MAGnesium SULfate (USP) 2 gm recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIfentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIPHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMORphine 1 mg/mL (Morphine Sulfate, USP 250mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIEPINEPHrine (USP) 4 mg, 5% Dextrose For Inj recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMidazolam 1 mg/mL (Midazolam HCL USP 30 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMORphine 1 mg/mL (Morphine Sulfate, USP 100mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIfentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHeparin in NS (Heparin Sodium, USP, 0.9% Sodium Chloride recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIfentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IINORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS II0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIePHEDrine 50mg, 50 mg/ (5 mg per mL) (Ephedrine Sulfate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IINORepiNEPHrine4mg (Norepinephrine Bitartrate recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIHYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIMidazolam 1 mg/mL (Midazolam HCL (USP) 55 mg recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIVancomycin 1.25gm in D5W ( Vancomycin HCL (USP) 1.25 gm recalledAvella of Deer Valley Inc. Store 38SterilityNationwide
CLASS IIEPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) Volume recalledAvella of Deer Valley Inc. Store 38SterilityNationwide

More recalls from Avella of Deer Valley Inc. Store 38

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