Multiple Hypotension Drugs Recalled

Prompted by sterility concerns, SterRx is recalling several norepinephrine and phenylephrine products. The voluntary recalls are included in the January 5, 2022, US Food and Drug Administration (FDA) Enforcement Report.

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

• norepinephrine in 0.9% sodium chloride injection, 16 mg per 250 mL (64 mcg per mL, NDC 70324-926-01), from lots S21082/BQV (Exp. 11/13/21), S21102/BRM (Exp. 11/28/21), S21135/BST (Exp. 12/14/21), S21166/BTX (Exp. 1/7/22), S21178/BUJ (Exp. 1/28/22), S21226/BVZ (Exp. 2/5/22), S21237/BWI (Exp. 2/7/22), S21242/BWM (Exp. 2/13/22), S21280/BXX (Exp. 3/11/22), S21302/BYS (Exp. 3/21/22), S21345/CAE (Exp. 4/23/22), and S21424/CDG (Exp. 5/28/22);
• norepinephrine in 0.9% sodium chloride injection, 4 mg per 250 mL (18 mcg per mL, NDC 70324-651-01), from lots S20415/BKY (Exp. 11/12/21), S20418/BLB (Exp. 11/13/21), S20452/BMI (Exp. 12/5/21), S20463/BMT (Exp. 12/9/21), S20464/BMU (Exp. 12/18/21), S20478/BNF (Exp. 12/23/21), S21021/BOI (Exp. 1/6/22), S21033/BOU (Exp. 1/20/22), S21047/BPH (Exp. 1/21/22), S21059/BPU (Exp. 1/28/22), S21094/BRE (Exp. 2/18/22), S21117/BSB (Exp. 3/3/22), S21118/BSC (Exp. 3/10/22), S21138/BSW (Exp. 3/17/22), S21227/BWA (Exp. 5/7/22), S21239/BWK (Exp. 5/12/22), S21279/BXW (Exp. 6/5/22), S21295/BYL (Exp. 6/16/22), S21298/BYO (Exp. 6/18/22), S21339/BZZ (Exp. 7/16/22), S21346/CAF (Exp. 7/21/22), S21355/CAO (Exp. 7/28/22), S21370/CBD (Exp. 8/4/22), S21372/CBF (Exp. 8/7/22), and S21438/CDS (Exp. 9/4/22);
• norepinephrine in 0.9% sodium chloride injection, 8 mg per 250 mL (32 mcg per mL, NDC 70324-676-01), from lots S21162/BTT (Exp. 11/13/21), S21163/BTU (Exp. 11/13/21), S21167/BTY (Exp. 11/19/21), S21174/BUF (Exp. 11/20/21), S21175/BUG (Exp. 11/21/21), S21217/BVS (Exp. 12/12/21), S21218/BVT (Exp. 12/12/21), S21219/BVU (Exp. 12/16/21), S21241/BWL (Exp. 12/24/21), S21281/BXY (Exp. 1/20/22), S21282/BXZ (Exp. 1/23/22), S21283/BYA (Exp. 1/22/22), S21297/BYN (Exp. 1/28/22), S21340/CAA (Exp. 2/27/22), S21342/CAC (Exp. 3/5/22), S21352/CAL (Exp. 3/6/22), S21359/CAS (Exp. 3/11/22), S21362/CAV (Exp. 3/12/22), S21368/CBB (Exp. 3/13/22), S21369/CBC (Exp. 3/19/22), S21415/CCX (Exp. 4/7/22), S21419/CDB (Exp. 4/7/22), and S21434/CDP (Exp. 4/16/22);
• norepinephrine in 5% dextrose injection, 8 mg per 250 mL (32 mcg per mL, NDC 70324-476-01), from lot S21409/CCR (no expiration date provided);
• norepinephrine in 5% dextrose injection, 16 mg per 250 mL (64 mcg per mL, NDC 70324-002-01), from lot S21194/CDW (no expiration date provided);
• phenylephrine in 0.9% sodium chloride, 20 mg per 250 mL (80 mcg per mL, NDC 70324-701-01), from lots S21086/BQW (Exp. 12/14/21), S21149/BTH (Exp. 1/23/22), S21159/BTQ (Exp. 1/30/22), S21265/BXI (Exp. 4/3/22), S21305/BYU (Exp. 4/24/22), and S21311/BZA (Exp. 4/26/22);
• phenylephrine in 0.9% sodium chloride injection, 40 mg per 250 mL (160 mcg per mL, NDC 70324-252-01), from lots S21087/BQX (Exp. 12/16/21), S21151/BTJ (Exp. 1/24/22), S21186/BUQ (Exp. 2/14/22), S21189/BUS (Exp. 2/16/22), S21266/BXJ (Exp. 4/3/22), S21307/BYW (Exp. 4/24/22), and S21313/BZC (Exp. 4/27/22); and
• phenylephrine in 0.9% sodium chloride injection, 50 mg per 250 mL (200 mcg per mL, NDC 70324-901-01), from lots S21088/BQY (Exp. 12/19/21), S21152/BTK (Exp. 1/25/22), S21161/BTS (Exp. 1/31/22), S21289/BYG (Exp. 4/4/22), S21309/BYY (Exp. 4/25/22), S21314/BZD (Exp. 5/2/22), and S21378/CBL (Exp. 6/12/22).

SterRx initiated the recalls November 12, 2021. The FDA designated them Class II on December 29, 2021. The classification communicates that use of the products could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Norepinephrine and phenylephrine are prescription vasopressors.