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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Avella of Deer Valley, Inc. Store 38: Labetalol and Magnesium Solution Recalled for Incorrect Barcode Labels

Agency Publication Date: February 13, 2019
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Summary

Avella of Deer Valley is recalling approximately 16,540 units of Labetalol HCL injectable solution and Magnesium Sulfate compounded bags due to a labeling error. The product labels contain a 2D barcode that, when scanned, displays an incorrect expiration date that does not match the correct date printed on the front of the label. This recall includes Labetalol 20mg/4mL syringes and various Magnesium Sulfate 1gm and 2gm IV bags sold in 13 states.

Risk

If a healthcare provider relies on the scanned barcode rather than the printed label, they may accidentally use a medication that has reached its beyond-use date. This could lead to the administration of a drug that is less effective or potentially unstable, which may result in sub-optimal treatment for patients.

What You Should Do

  1. Check the front face of your product labels and compare them against the 2D barcode information if you use scanning technology for medication management.
  2. Identify affected Labetalol 20mg/4mL syringes (NDC 42852-822-71) with lot numbers 138-20182712@49, 138-20182712@63, 138-20182712@89, 138-20182712@90, 138-20182712@93, 138-20183112@88, 138-20183112@89, 138-20183112@91, or 138-20190201@96.
  3. Identify affected Magnesium 1gm or 2gm Sulfate bags (NDCs 42852-901-05, 42852-902-05, 42852-907-05) by checking for lot numbers such as 138-20182409@31, 138-20182509@110, 138-20180210@76, and others listed in the product details.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you have been administered these medications or have them in your inventory.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Avella Specialty Pharmacy at (877) 794-0404 for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider guidance and product return

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

Affected Products

Product: Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe
Model:
NDC 42852-822-71
Lot Numbers:
138-20182712@49
138-20182712@63
138-20182712@89
138-20182712@90
138-20182712@93
138-20183112@88
138-20183112@89
138-20183112@91
138-20190201@96
Date Ranges: BUD 4/6/2019, BUD 4/10/2019, BUD 4/12/2019
Product: MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag
Model:
NDC 42852-901-05
Lot Numbers:
138-20182409@31
Date Ranges: BUD 12/23/2018
Product: MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag
Model:
NDC 42852-902-05
Lot Numbers:
138-20182509@110
138-20182509@111
138-20182509@112
138-20180210@76
138-20180210@86
138-20180410@66
138-20183110@43
138-20183110@44
138-20180111@84
138-20180111@85
138-20180611@36
138-20180611@39
138-20180611@52
138-20180611@60
138-20181911@125
138-20181911@126
138-20182011@56
Date Ranges: BUD 12/24/2018, BUD 12/31/2018, BUD 1/2/2019, BUD 1/29/2019, BUD 1/30/2019, BUD 2/4/2019, BUD 2/17/2019, BUD 2/18/2019
Product: MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL
Model:
NDC 42852-907-05
Lot Numbers:
138-20181909@53
138-20182009@10
138-20182009@2
138-20182009@3
138-20182009@4
138-20182009@5
138-20182009@6
138-20182009@7
138-20182009@8
138-20182009@9
138-20182109@35
138-20180410@54
138-20180510@107
138-20180510@108
138-20180510@92
138-20182210@97
138-20181212@103
Date Ranges: BUD 12/18/2018, BUD 12/19/2018, BUD 12/20/2018, BUD 1/2/2019, BUD 1/3/2019, BUD 1/20/2019, BUD 3/12/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82102
Status: Resolved
Manufacturer: Avella of Deer Valley, Inc. Store 38
Sold By: Avella Specialty Pharmacy
Manufactured In: United States
Units Affected: 4 products (2,840 4mL syringes; 250 52 mL bags; 4,950 54 mL bags; 8,500 54 mL bags)
Distributed To: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas
Agency Last Updated: March 12, 2019

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.