D-1000-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- February 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,500 54 mL bags
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Code Information
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.