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FDAFDA · Food and drugs·Recall number D-1000-2019

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.

Published February 20, 2019 · Recall initiated: February 8, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Avella of Deer Valley, Inc. Store 38
Distributor
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Lot
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; 138-20182210@97, BUD 1/20/2019; 138-20181212@103, BUD 3/12/2019.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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