Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1000-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 8, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 8,500 54 mL bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
Original FDA data
Every field from FDA enforcement report D-1000-2019, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 82102
- Address
- 24416 N 19th Ave
- 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.
- Postal code
- 85085-1887
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-1000-2019
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Product quantity
- 8,500 54 mL bags
- Termination date
- Feb 25, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
- Recall initiation date
- Feb 8, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2019