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Class IIDrug recallTerminated

MAGNESIUM CHL recall

Recalled by Medaus, Inc. of Birmingham, AL · FDA report 07/20/2016

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Terminated
Closed 06/16/2017
Recall started
05/13/2016
Distribution
Nationwide

Reason for recall

Lack of Assurance of Sterility

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Lot and code info
a) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16. b) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16.
Quantity
5000 mL in Vials
Recall number
D-1211-216
Event ID
74466
Initiated by
Voluntary: Firm initiated

Where it was distributed

U.S. Nationwide, Japan, and New Zealand.

  • Nationwide

Recall timeline

  1. 05/13/2016Firm started the recall
  2. 07/08/2016FDA classified it as Class II
  3. 07/20/2016Published in the FDA enforcement report
  4. 06/16/2017FDA closed (terminated) the recall

All products in this recall

88 products under event 74466

More recalls from Medaus

Frequently asked questions

Why was MAGNESIUM CHL recalled?
Lack of Assurance of Sterility
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?
U.S. Nationwide, Japan, and New Zealand.
Is this recall still active?
The FDA lists the recall as terminated (closed 06/16/2017). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 07/20/2016 · Do not rely on openFDA to make decisions regarding medical care