News & Press: Patient Safety

Recall Alert: Injectable Products by SCA Pharmaceuticals

Monday, October 23, 2017  

SIS Patient Safety Alert 10/23/2017: Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

This is an important alert from the Spine Intervention Society. We send out Patient Safety Alerts when we receive important information regarding products or services that can impact your patients' safety. When companies announce a recall, market withdrawal, or safety alert, the Food and Drug Administration (FDA) posts the company's announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.

BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.

RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.fda.gov/MedWatch/report
  • 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.

Read the FDA MedWatch Safety Alert, for details on the specific injectable products and lots.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 10/23/2017)


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