FDA Recalls Dexmedetomidine Injection Due to Contamination Concerns
What happened
The FDA has posted a notice regarding product contamination involving Par Pharmaceutical. The recall affects two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection (NDC 42023-187-01). Particles identified as cellulose or stopper material were found in the product. The affected lots are 87558 and 88802, and the recall extends to the hospital level.
From medicaldaily.com
Why it matters
The product, a sedative used in intensive care units, carries a 'reasonable probability of causing life-threatening adverse health consequences.' Par Pharmaceutical has been asked to arrange returns through Inmar, Inc., and wholesalers and hospital pharmacies are instructed to stop use and distribution immediately.
The FDA is investigating a product recall after discovering contamination traced back to an ingredient supplier. The main manufacturer, which uses online retailers, has been forced to pull the product from shelves.
From medicaldaily.com
Who's involved
- Par PharmaceuticalManufacturer of the affected lots of Dexmedetomidine HCl
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Par PharmaceuticalSpeculative
Par Pharmaceutical could face significant supply chain disruption due to the mandatory withdrawal of core products.
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The entities involved
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