FDA-Drug2013-09-18Class II

Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627

Wellness Pharmacy, Inc.
Hazard

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Sold states
Nationwide and Puerto Rico
Affected count
590 Vials
Manufactured in
3401 Independence Drive Suite 231, N/A, Birmingham, AL, United States
Products
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1031-2013

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