NAFDAC Alert: Recall of Alvogen Clindamycin Injection

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The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public that Alvogen is conducting a voluntary recall of seven (7) lots of Clindamycin Injection USP ADD-Vantage Vials, manufactured for Alvogen by Hospira Inc., to the hospital or retail level.

Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Reason for recall

On June 16, 2017, Alvogen announced that it was voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials in response to microbial growth detected during a routine manufacturing simulation. This growth shows the potential for possible contamination of product. Hospira, a Pfizer company, also recalled several other products for the same reason.

Possible associated risk

According to NAFDAC, the administration of this product may cause adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

Details of affected products

Lot number Expiration Date Strength          NDC #
68-104-EV 07/31/2018 600mg/4mL 47781-463-69
68-105-EV 07/31/2018 900mg/6mL 47781-464-69
68-106-EV 07/31/2018 900mg/6mL 47781-464-69
73-154-EV 12/31/2018 300mg/2mL 47781-462-69
73-155-EV 12/31/2018 600mg/4mL 47781-463-69
73-156-EV 12/31/2018 600mg/4mL 47781-463-69
73-157-EV 12/31/2018 900mg/6mL 47781-464-69

Healthcare providers’ action

  • Healthcare providers in possession of the affected lots of product should discontinue their use and submit them to the nearest NAFDAC office.
  • Healthcare providers and patients should report adverse reactions associated with the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
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About Bob Aroture 500 Articles
Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: baroture@nlipw.com

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