Avella recalls magnesium sulfate bags with incorrect barcode expiration dates
Avella of Deer Valley is recalling 250 bags of compounded magnesium sulfate due to incorrect expiration dates in the 2D barcodes.
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 minor labeling error regarding expiration dates in barcodes, which fits the criteria for moderate severity.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 250 bags of MAGnesium 1gm sulfate added to D5W 50 mL. The product is a sterile single-use bag compounded by Avella Specialty Pharmacy in Phoenix, Arizona.
The recall is due to a labeling error where the expiration date included within the 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label. The affected lot number is 138-20182409@31 with a best-use date of 12/23/2018.
The product was distributed to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, and Texas. Healthcare providers and patients should check their inventory for this specific lot and contact the recalling firm for instructions.
The recalled product
- Product
- MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05.
- 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 (2)
- Lot number: 138-20182409@31
- BUD 12/23/2018
Distribution
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.
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