CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate recalled
Avella of Deer Valley Inc. Store 38 is recalling fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, 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 codes Lot #: 5/14/18 0913 320-25087Y, BUD 6/28/2018.
Quantity recalled 15 cassettes
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-0944-2018
FDA event ID 80307
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
Timeline
12 Jun 2018 Recall initiated by company 19 Jul 2018 Classified by FDA +37 days 25 Jul 2018 Published 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
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87
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 #: 5/14/18 0913 320-25087Y, BUD 6/28/2018.
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 .
Reported Class Recall Company Reason Where 25 Jul 2018 CLASS II 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II ceFAZolin 2 gm in NS ceFAZolin Sodium (USP) 2gm recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II ePHEDrine Sulfate, USP 50mg recalled by Avella of Deer Valley, Inc. Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II NORepiNEPHrine 8 mg (norepinephrine Bitartrate recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Heparin in 5% Dextrose (Heparin Sodium recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MORphine 150 mg (Morphine Sulfate, USP 150mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Heparin in 5% Dextrose recalled by Avella of Deer Valley, Inc. Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MAGnesium 1gm in NS (MAGnesium SULfate (USP) 1 gm recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II NORepiNEPHrine4mg (Norepinephrine Bitartrate recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MAGnesium 2gm in NS (MAGnesium SULfate (USP) 2 gm recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MORphine 1 mg/mL (Morphine Sulfate, USP 250mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Midazolam 1 mg/mL (Midazolam HCL USP 30 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MORphine 1 mg/mL (Morphine Sulfate, USP 100mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II MAGnesium 4gm in NS (MAGnesium SULfate (USP) 4 gm recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Heparin in NS (Heparin Sodium, USP, 0.9% Sodium Chloride recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II ePHEDrine 50mg, 50 mg/ (5 mg per mL) (Ephedrine Sulfate recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II NORepiNEPHrine4mg (Norepinephrine Bitartrate recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II Vancomycin 1.25gm in D5W ( Vancomycin HCL (USP) 1.25 gm recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide 25 Jul 2018 CLASS II EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) Volume recalled Avella of Deer Valley Inc. Store 38 Sterility Nationwide
More recalls from Avella of Deer Valley Inc. Store 38 All 50