Sterility Concerns Prompt Anaphylaxis Drug Recall

SCA Pharmaceuticals is pulling 2 lots of epinephrine HCl 4 mg in 0.9% sodium chloride 250 mL (NDC 70004-0613-40), according to the August 2, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The recalled drugs are from lot 20170508@51 (beyond-use date 9/10/17) and lot 20170503@17 (beyond-use date 9/5/17). The products were distributed across the country.

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Sterility concerns prompted SCA Pharmaceuticals to issue the voluntary recall July 14, 2017. The FDA designated it Class II, indicating exposure to the product could cause temporary or medically reversible health consequences but that the probability of serious adverse effects is remote.

Epinephrine HCl is used to treat a life-threatening allergic reaction or shock caused by a severe bacterial infection.

—Jolynn Tumolo