Friday, 15 January 2016 00:00

Voluntary Recall Of Auvi-Q (Epinephrine Injection Usp)

The attention of the Agency has been drawn to the voluntary recall of Auvi-Q (Epinephrine injection USP) by Sanofi US. Auvi-Q (Epinephrine injection USP) is an injection given to the outer thigh used to treat life-threatening allergic reaction (anaphylaxis). It is for immediate self (or caregiver) administration and does not take the place of emergency medical care. It is used with caution in patients with heart diseases or other heart related symptoms. It works by narrowing and opening up airways and prevents drop in blood pressure and makes breathing easier.

The recall is due to the discovery by Sanofi that all Auvi-Q 0.15mg and 0.3mg strengths of lot numbers 2299596 through 3037230 which expires March 2016 through December 2016 have inaccurate dosage delivery (delivers inadequate doses).

Possible Risks

Patient with serious allergic reaction (anaphylaxis) who is not given intended dose when needed due to faulty dose delivery can have worsened health consequences including death.

Recalled product details

•           Manufacturer: Sanofi US

•           Expiration: March 2016 through December 2016

•           Lot number: 2299596 through 3037230

Health care Provider’s action

•           Make patient aware of the  possible risk of under dosing

•           Notify the Agency immediately of any available batch for further necessary action

•           Report adverse events or side effects related to the use of these products to NAFDAC      PRASCOR (20543, toll free from all network) or via individual case safety report forms and also encourage patients to do the same.

NAFDAC…safeguarding the health of the nation

Read 9375 times Last modified on Wednesday, 18 May 2016 14:32



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