penicillin v potassium FDA Alerts

The FDA Alert(s) below may be specifically about penicillin v potassium or relate to a group or class of drugs which include penicillin v potassium.

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for penicillin v potassium

Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin

Mar 20, 2014

Audience: Consumer

Includes Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX

[Posted 03/20/2014]

ISSUE: Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process. In patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. See the press release for a complete listing of products affected by this recall.

BACKGROUND: Pleo Homeopathic drug products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.

RECOMMENDATION: Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase. Consumers with questions regarding this recall can contact Terra-Medica’s Customer Service Department at (888) 415-0535, ext. 1, Monday through Friday between 8-5pm, Pacific Time Zone.

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:

• 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

[03/20/2014 - Press Release - Terra-Medica]
[03/20/2014 - Product Photos - FDA]
 

Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension)

Nov 30, 2004

Audience: Infectious disease specialists and other healthcare professionals

King Pharmaceuticals and FDA reminded healthcare professionals of postmarketing reports of inappropriate use of Bicillin C-R to treat patients infected with syphilis. Bicillin L-A is the only currently approved penicillin G benzathine product indicated for the treatment of syphilis and Bicillin C-R should not be administered in place of Bicillin L-A. Administration of Bicillin C-R instead of Bicillin L-A in the treatment of syphilis may result in inadequate treatment.

In addition, a BLACK BOX WARNING has been added to the prescribing information of both products to emphasize that these products should only be administered by deep intramuscular injection. They are not intended for intravenous administration and inadvertent intravenous administration of penicillin G benzathine has been associated with cardiorespiratory arrest and death.

[November, 2004 - Letter - King Pharmaceuticals]
[November, 2004 - Bicillin C-R Label - King Pharmaceuticals]
[November, 2004 - Bicillin L-A Label - King Pharmaceuticals]

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