Anesthesia Drug Recalled

SCA Pharmaceuticals is recalling more than 20,000 ketamine syringes because the syringe caps are potentially defective and could compromise sterility of the drug, according to the January 13, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following ketamine products, which were distributed to hospitals throughout the United States:

• ketamine 50 mg/5 mL in 0.9% sodium chloride injection (10 mg/mL), CII, 5-mL single-dose syringe (barcode 70004043009), from lots 1220023040 (Beyond Use Date [BUD] 1/19/21), 1220023070 (BUD 1/21/21), 1220023105 (BUD 1/25/21), 1220023158 (BUD 1/26/21), 1220023315 (BUD 2/1/21), 1220023342 (BUD 2/2/21), 1220023431 (BUD 2/4/21), 1220023471 (BUD 2/3/21), 1220023481 (BUD 2/4/21), and 1220023509 (BUD 2/8/21); and
• ketamine 100 mg/10 mL in 0.9% sodium chloride injection (10 mg/mL), CII, 10-mL single-dose syringe (barcode 70004043012), from lots 1220023076 (BUD 1/24/21), 1220023549 (BUD 2/9/21), 1220023040 (BUD 1/19/21), 1220023070 (BUD 1/21/21), 1220023105 (BUD 1/25/21), 1220023158 (BUD 1/26/21), 1220023315 (BUD 2/1/21), 1220023342 (BUD 2/2/21), 1220023431 (BUD 2/4/21), 1220023471 (BUD 2/3/21), 1220023481 (BUD 2/4/21), and 1220023509 (BUD 2/8/21).  

SCA Pharmaceuticals voluntarily initiated the recall December 17, 2020. On January 7, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Ketamine is a prescription general anesthetic.

—Jolynn Tumolo