The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1000-2019·Announced 2019-02-20

Avella recalls magnesium sulfate bags with incorrect barcode expiration dates

Avella of Deer Valley is recalling 8,500 bags of compounded magnesium sulfate because the 2D barcodes contain incorrect expiration dates that do not match the label.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect barcode expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 8,500 bags of Magnesium 2 gm sulfate added to NS 50 mL. The product is a sterile single-use bag, 54 mL, compounded by Avella Specialty Pharmacy in Phoenix, Arizona. The recall involves specific lots with expiration dates ranging from December 18, 2018, to March 12, 2019.

The recall was initiated because the product labels contain a Two-Dimensional (2D) barcode that, when scanned, reveals batch-specific information including the expiration date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

The affected product was distributed to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, and Texas. Consumers and healthcare providers should check their inventory for the specific lot codes and expiration dates listed in the recall notice and stop using the product if it matches the recalled lots.

The recalled product

Product
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05.
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Compounded Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 138-20181909@53
  • BUD 12/18/2018
  • 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
  • BUD 12/19/2018
  • 138-20182109@35
  • BUD 12/20/2018
  • 138-20180410@54
  • BUD 1/2/2019
  • 138-20180510@107
  • 138-20180510@108
  • 138-20180510@92
  • BUD 1/3/2019

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 4 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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