MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Sp...

FDA Drug Recall #D-1000-2019 — Class II — February 8, 2019

Recall Summary

Recall Number D-1000-2019
Classification Class II — Moderate risk
Date Initiated February 8, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Avella of Deer Valley, Inc. Store 38
Location Phoenix, AZ
Product Type Drugs
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.

Lot / 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.

Other Recalls from Avella of Deer Valley, Inc. Store 38

Recall # Classification Product Date
D-0152-2020 Class II Povidone Iodine, 5% Ophthalmic Solution, 5 mL p... Sep 18, 2019
D-1308-2019 Class II Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefil... May 3, 2019
D-0997-2019 Class II Labetalol 20mg, HCL, USP Injectable Solution, 2... Feb 8, 2019
D-0998-2019 Class II MAGnesium 1gm sulfate, added to D5W 50 mL, Volu... Feb 8, 2019
D-0999-2019 Class II MAGnesium 2gm sulfate, added to D5W 50 mL, Volu... Feb 8, 2019

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.