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www.fdanews.com/articles/61747-link-pharmaceuticals-recall-prompts-mhra-class-2-alert

LINK PHARMACEUTICALS' RECALL PROMPTS MHRA CLASS 2 ALERT

August 16, 2006

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Class 2 drug alert informing healthcare professionals that Link Pharmaceuticals is recalling its Pabrinex Intravenous High Potency Injection due to the presence of particulate contamination. This product is marketed as both an intravenous and intramuscular presentation, but the recall is limited to a single batch of the intravenous presentation.

This product is supplied as pairs of 5-mL ampoules, which are mixed prior to administration. The cartons contain 10 pairs of ampoules. The individual ampoules are lot number 028, but the carton lot number is 028725. The expiration date is September 2007.

Recipients are asked to quarantine any remaining stock and return it to their supplier for credit or replacement.