Sodium Bicarbonate IV Bags Recalled

SterRx is recalling more than 130,000 bags of sodium bicarbonate in 5% dextrose injection due to a lack of sterility assurance, according to 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:

• sodium bicarbonate in 5% dextrose injection, 150 mEq per 1000 mL (12.6 mg per mL; NDC 70324-326-01), from lots S20483/BNJ (Exp. 11/23/21), S20484/BNK (Exp. 11/24/21), S20485/BNL (Exp. 11/25/21), S21008/BNV (Exp. 12/3/21), S21010/BNX (Exp. 12/9/21), S21025/BOM (Exp. 12/10/21), S21026/BON (Exp. 12/15/21), S21027/BOO (Exp. 12/16/21),  S21035/BOW (Exp. 12/17/21), S21045/BPF (Exp. 12/18/21), S21046/BPG (Exp. 12/21/21), S21050/BPK (Exp. 12/22/21), S21054/BPO (Exp. 12/24/21), S21055/BPQ (Exp. 12/25/21), S21061/BPW (Exp. 12/28/21), S21062/BPX (Exp. 12/29/21), S21063/BPY (Exp. 12/30/21), S21064/BPZ (Exp. 12/31/21), S21069/BQE (Exp. 12/31/21), S21073/BQI (Exp. 1/4/22), S21074/BQJ (Exp. 1/5/22), S21076/BQL (Exp. 1/6/22), S21077/BQM (Exp. 1/7/22), S21081/BQQ (Exp. 1/20/22), S21083/BQS (Exp. 1/22/22), S21084/BQT (Exp. 1/25/22), S21110/BRU (Exp. 1/26/22), S21111/BRV (Exp. 1/27/22), S21112/BRW (Exp. 1/27/22), S21113/BRX (Exp. 1/28/22), S21114/BRY (Exp. 2/1/22), S21115/BRZ (Exp. 2/1/22), S21123/BSH (Exp. 2/2/22), S21124/BSI (Exp. 2/3/22), S21126/BSK (Exp. 2/3/22), S21127/BSL (Exp. 2/4/22), S21128/BSM (Exp. 2/4/22), S21129/BSN (Exp. 2/5/22), S21168/BTZ (Exp. 3/10/22), S21169/BUA (Exp. 3/11/22), S21176/BUH (Exp. 3/15/22), S21181/BUL (Exp. 3/17/22), S21182/BUM (Exp. 3/17/22), S21270/BXN (Exp. 5/26/22), S21274/BXR (Exp. 5/26/22), S21321/BZH (Exp. 6/1/22), S21322/BZI (Exp. 6/2/22), S21323/BZJ (Exp. 6/3/22), S21324/BZK (Exp. 6/3/22), S21325/BZL (Exp. 6/7/22), S21329/BZP (Exp. 6/8/22), S21336/BZW (Exp. 6/14/22), S21337/BZX (Exp. 6/15/22), S21338/BZY (Exp. 6/16/22), S21341/CAB (Exp. 6/17/22), S21343/CAD (Exp. 6/18/22), S21348/CAH (Exp. 6/23/22), S21350/CAJ (Exp. 6/24/22), S21351/CAK (Exp. 6/28/22), S21357/CAQ (Exp. 7/1/22), S21360/CAT (Exp. 7/2/22), S21363/CAW (Exp. 7/5/22),  S21366/CAZ (Exp. 7/7/22), S21374/CBH (Exp. 7/8/22), S21376/CBJ (Exp. 7/8/22), S21377/CBK (Exp. 7/12/22), S21381/CBO (Exp. 7/13/22), S21384/CBR (Exp. 7/13/22), S21387/CBU (Exp. 7/13/22), S21390/CBX (Exp. 7/14/22), S21392/CBZ (Exp. 7/14/22), S21393/CCA (Exp. 7/15/22), S21396/CCD (Exp. 7/15/22), S21397/CCF (Exp. 7/19/22), S21399/CCH (Exp. 7/19/22), S21401/CCJ (Exp. 7/20/22), and S21404/CCM (Exp. 7/21/22); and
• sodium bicarbonate in 5% dextrose injection (NDC 70324-326-03) from lots S20459/BMP (Exp. 11/17/21), S20472/BMZ (Exp. 11/18/21), and S20473/BNA (Exp. 11/18/21).

SterRx voluntarily initiated the recall November 12, 2021. On December 29, 2021, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Sodium bicarbonate injection is a prescription alkalinizing agent.