Medications & Supplements/Prescription Drugs

Avella of Deer Valley, Inc. Store 38: Various Compounded Injectable Drugs Recalled for Sterility and Leakage Risks

Agency Publication Date: July 19, 2018

Summary

Avella of Deer Valley, Inc. Store 38 is recalling approximately 39,027 units of various compounded medications, including syringes, bags, and pumps containing drugs like Fentanyl, Morphine, Heparin, and Epinephrine. The recall was initiated because the bags may leak, which creates a lack of assurance that the medications remain sterile. If a sterile injectable medication is contaminated with bacteria or fungi, it can lead to serious, life-threatening infections.

Risk

Potential leakage in the intravenous bags and syringes compromises the sterile barrier of the medication. Injecting a non-sterile drug directly into the bloodstream or body cavity poses a significant risk of systemic infection and other serious medical complications.

What You Should Do

Identify your medication by checking the NDC and Lot Numbers on the label. Affected products include various lots of Fentanyl, Morphine, Hydromorphone, Heparin, Epinephrine, Norepinephrine, Magnesium Sulfate, Midazolam, Phenylephrine, Cephasolin, Ephedrine, and Vancomycin.
Check for specific lot numbers such as Lot 138-20181505 (Heparin), Lot 138-20181005 (Vancomycin), and others with 'Beyond Use Dates' (BUD) ranging from June 2018 through September 2018 as listed on the product packaging.
Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on alternative treatments.
Return any unused recalled products to the pharmacy where they were dispensed to receive a refund.
Contact the manufacturer, Avella of Deer Valley / Advanced Pharma, at their Phoenix location (24416 N 19th Ave, Phoenix, AZ 85085) for further instructions regarding the return process.
For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consumers should stop using the products and return them to the dispensing pharmacy for a refund.

Affected Products

Product: 0.2% ROPivacaine - OnQ Pump (550 ml)

Model:

NDC 42852-661-02

Lot Numbers:

5/14/18 0749 525-66102 (BUD 6/13/2018)

5/22/18 0837 495-66102 (BUD 6/21/2018)

Date Ranges: BUD 06/13/2018, BUD 06/21/2018

Product: ceFAZolin 2 gm in NS 100mL (110 mL)

Model:

NDC 42852-604-10

Lot Numbers:

4/27/18 2002 60410P (BUD 6/26/2018)

4/27/18 2030 60410P (BUD 6/26/2018)

Date Ranges: BUD 06/26/2018

Product: ePHEDrine 50mg/10 mL Syringe (10 mL)

Model:

NDC 42852-805-61

Lot Numbers:

3/5/18 8055 80561S (BUD 7/3/2018)

3/5/18 0514 80561S (BUD 7/3/2018)

3/5/18 5259 80561S (BUD 7/3/2018)

3/5/18 6131 80561S (BUD 7/3/2018)

3/5/18 5641 80561S (BUD 7/3/2018)

5/10/18 1312 80561S (BUD 9/7/2018)

5/10/18 1322 80561S (BUD 9/7/2018)

Date Ranges: BUD 07/03/2018, BUD 09/07/2018

Product: EPINEPHrine 4 mg in 5% Dextrose (254 mL)

Model:

NDC 15082-855-25

Lot Numbers:

5/4/18 0300 58-85525P (BUD 6/18/2018)

5/10/18 1435 262-85525P (BUD 6/24/2018)

5/10/18 1127 558-85525P (BUD 6/24/2018)

5/11/18 1327 457-85525P (BUD 6/25/2018)

5/14/18 0302 295-85525P (BUD 6/28/2018)

5/17/18 0500 558-85525P (BUD 7/1/2018)

5/24/18 1005 57-85525P (BUD 7/7/2018)

5/24/18 1328 295-85525P (BUD 7/7/2018)

5/25/18 0302 295-85525P (BUD 7/9/2018)

5/30/18 0936 262-85525P (BUD 7/14/2018)

5/31/18 0805 558-85525P (BUD 7/17/2018)

Date Ranges: BUD 06/18/2018 - 07/17/2018

Product: HEPARIN 25,000 Units in 5% Dextrose (255 mL)

Model:

NDC 42852-729-25

Lot Numbers:

138-20181505@92 (BUD 8/23/2018)

138-20181605@78 (BUD 8/24/2018)

Date Ranges: BUD 08/23/2018, BUD 08/24/2018

Product: fentaNYL 10 mcg per mL Syringe (1 mL)

Model:

NDC 15082-210-70

Lot Numbers:

5/3/18 0317 142-21070S (BUD 8/1/2018)

5/10/18 0512 144-21070S (BUD 8/8/2018)

6/1/18 0305 142-21070S (BUD 8/30/2018)

6/4/18 0505 252-21070S (BUD 9/2/2018)

Date Ranges: BUD 08/01/2018 - 09/02/2018

Product: Vancomycin 1.25gm in D5W 250 mL (262 mL)

Model:

NDC 42852-617-25

Lot Numbers:

138-20181005@92 (BUD 7/9/2018)

138-20181005@91 (BUD 7/9/2018)

138-20181005@90 (BUD 7/9/2018)

138-20181405@78 (BUD 7/13/2018)

138-20181605@61 (BUD 7/15/2018)

Date Ranges: BUD 07/09/2018 - 07/15/2018

Product: MORphine 1 mg/mL in 0.9% Sodium Chloride (100 mL)

Model:

NDC 42852-241-10

Lot Numbers:

5/15/18 6413 24110P (BUD 9/12/2018)

5/16/18 0744 24110P (BUD 9/13/2018)

Date Ranges: BUD 09/12/2018, BUD 09/13/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80307

Status: Resolved

Manufacturer: Avella of Deer Valley, Inc. Store 38

Sold By: Vidant Medical Center; Peninsular Regional Medical Center; Hunt Regional Medical Center; Gaston Memorial Hospital; Parkland Memorial Hospital; Methodist St. John Hospital; Cook Children's Medical Center; Methodist Dallas Medical Center; Adventist Medical Center Hanford; Salt Lake Regional Med Ctr; Desert Regional Med Ctr; Methodist Willowbrook Hospital; Coral Gables Hospital; Redlands Community Hospital Pharmacy

Manufactured In: United States

Units Affected: 37 products (40 pumps; 2,500 bags; 5400 syringes; 420 bags; 700 bags; 120 syringes; 240 bags; 275 syringes; 100 bags; 1860 bags; 1500 bags; 4,280 bags; 200 bags; 1,352 bags; 20 bags; 500 syringes; 15 cassettes; 100 syringes; 100 cassettes; 900 bags; 40 bags; 480 syringes; 660 bags; 25 bags; 175 bags; 130 bags; 740 syringes; 220 bags; 110 syringes; 520 bags; 850 syringes; 2280 bags; 1290 bags; 120 bags; 10500 syringes; 225 syringes; 40 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your medication by checking the NDC and Lot Numbers on the label. Affected products include various lots of Fentanyl, Morphine, Hydromorphone, Heparin, Epinephrine, Norepinephrine, Magnesium Sulfate, Midazolam, Phenylephrine, Cephasolin, Ephedrine, and Vancomycin.

Check for specific lot numbers such as Lot 138-20181505 (Heparin), Lot 138-20181005 (Vancomycin), and others with 'Beyond Use Dates' (BUD) ranging from June 2018 through September 2018 as listed on the product packaging.

Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on alternative treatments.

Return any unused recalled products to the pharmacy where they were dispensed to receive a refund.

Contact the manufacturer, Avella of Deer Valley / Advanced Pharma, at their Phoenix location (24416 N 19th Ave, Phoenix, AZ 85085) for further instructions regarding the return process.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: 0.2% ROPivacaine - OnQ Pump (550 ml)

Model:

NDC 42852-661-02

Lot Numbers:

5/14/18 0749 525-66102 (BUD 6/13/2018)

5/22/18 0837 495-66102 (BUD 6/21/2018)

Date Ranges: BUD 06/13/2018, BUD 06/21/2018

Product: ceFAZolin 2 gm in NS 100mL (110 mL)

Model:

NDC 42852-604-10

Lot Numbers:

4/27/18 2002 60410P (BUD 6/26/2018)

4/27/18 2030 60410P (BUD 6/26/2018)

Date Ranges: BUD 06/26/2018

Product: ePHEDrine 50mg/10 mL Syringe (10 mL)

Model:

NDC 42852-805-61

Lot Numbers:

3/5/18 8055 80561S (BUD 7/3/2018)

3/5/18 0514 80561S (BUD 7/3/2018)

3/5/18 5259 80561S (BUD 7/3/2018)

3/5/18 6131 80561S (BUD 7/3/2018)

3/5/18 5641 80561S (BUD 7/3/2018)

5/10/18 1312 80561S (BUD 9/7/2018)

5/10/18 1322 80561S (BUD 9/7/2018)

Date Ranges: BUD 07/03/2018, BUD 09/07/2018

Product: EPINEPHrine 4 mg in 5% Dextrose (254 mL)

Model:

NDC 15082-855-25

Lot Numbers:

5/4/18 0300 58-85525P (BUD 6/18/2018)

5/10/18 1435 262-85525P (BUD 6/24/2018)

5/10/18 1127 558-85525P (BUD 6/24/2018)

5/11/18 1327 457-85525P (BUD 6/25/2018)

5/14/18 0302 295-85525P (BUD 6/28/2018)

5/17/18 0500 558-85525P (BUD 7/1/2018)

5/24/18 1005 57-85525P (BUD 7/7/2018)

5/24/18 1328 295-85525P (BUD 7/7/2018)

5/25/18 0302 295-85525P (BUD 7/9/2018)

5/30/18 0936 262-85525P (BUD 7/14/2018)

5/31/18 0805 558-85525P (BUD 7/17/2018)

Date Ranges: BUD 06/18/2018 - 07/17/2018

Product: HEPARIN 25,000 Units in 5% Dextrose (255 mL)

Model:

NDC 42852-729-25

Lot Numbers:

138-20181505@92 (BUD 8/23/2018)

138-20181605@78 (BUD 8/24/2018)

Date Ranges: BUD 08/23/2018, BUD 08/24/2018

Product: fentaNYL 10 mcg per mL Syringe (1 mL)

Model:

NDC 15082-210-70

Lot Numbers:

5/3/18 0317 142-21070S (BUD 8/1/2018)

5/10/18 0512 144-21070S (BUD 8/8/2018)

6/1/18 0305 142-21070S (BUD 8/30/2018)

6/4/18 0505 252-21070S (BUD 9/2/2018)

Date Ranges: BUD 08/01/2018 - 09/02/2018

Product: Vancomycin 1.25gm in D5W 250 mL (262 mL)

Model:

NDC 42852-617-25

Lot Numbers:

138-20181005@92 (BUD 7/9/2018)

138-20181005@91 (BUD 7/9/2018)

138-20181005@90 (BUD 7/9/2018)

138-20181405@78 (BUD 7/13/2018)

138-20181605@61 (BUD 7/15/2018)

Date Ranges: BUD 07/09/2018 - 07/15/2018

Product: MORphine 1 mg/mL in 0.9% Sodium Chloride (100 mL)

Model:

NDC 42852-241-10

Lot Numbers:

5/15/18 6413 24110P (BUD 9/12/2018)

5/16/18 0744 24110P (BUD 9/13/2018)

Date Ranges: BUD 09/12/2018, BUD 09/13/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80307

Status: Resolved

Manufacturer: Avella of Deer Valley, Inc. Store 38

Manufactured In: United States

Distributed To: Nationwide