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Calcium chloride FDA Alerts

The FDA Alerts below may be specifically about calcium chloride or relate to a group or class of drugs which include calcium chloride.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for calcium chloride

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

[Posted 08/18/2017]

ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
 
BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.

RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.

Health care professionals  are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


[08/18/2017- Press Release - Bella Pharmaceuticals]


Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

ISSUE: In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10% w/v, packaged in 10 mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. FDA has recently become aware that some units of this drug may still be on the market. Please check your inventory and crash boxes, quarantine and discontinue distribution and use of affected lots (see press release below for list of affected lots).

BACKGROUND: Calcium Chloride Intravenous Infusion 10% w/v is used as part of the resuscitation procedure following a cardiac arrest and for the treatment of low calcium levels. It is also used for arrhythmias associated with hypocalcaemia, hyperkalaemia or hypomagnesaemia. Because of the use of Calcium Chloride Intravenous Infusion prefilled syringes in emergency situations, and its use as a lifesaving drug, difficulty in the administration of the drug could create a potential risk by prohibiting or delaying the administration of the medication.

RECOMMENDATION:     

  •  Immediately examine your inventory and crash boxes, quarantine and discontinue distribution and use of these lots.
  • If you have the affected product, please contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
  • In addition, if you have further distributed the affected product, please identify your customers and notify them at once of this market withdrawal.  The customer should be instructed to contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
  • Additionally, Stericyle will notify your retail level customers that received the affected lots.  Provide a list of customers via Microsoft Excel file to mylan5322@stericycle.com within 10 business days.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 [07/14/2015 - Press Release - Mylan]


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