Subpotent Oxytocin Injection Recalled

SCA Pharmaceuticals is recalling 73,312 single-dose containers of oxytocin due to suspected subpotency, according to the May 3, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects oxytocin 30 units added to 0.9% sodium chloride, 500-mL, single-dose containers (NDC 70004-085-44), from:

• lots 1222043028 (Exp 4/11/23), 1222043029 (Exp 4/13/23), 1222043031 (Exp 4/12/23), 1222043032 (Exp 4/12/23), 1222043033 (Exp 4/13/23), 1222043034 (Exp 4/13/23), 1222043035 (Exp 4/14/23), 1222043036 (Exp 4/14/23), 1222043037 (Exp 4/18/23), 1222043038 (Exp 4/18/23), 1222043039 (Exp 4/19/23), 1222043040 (Exp 4/19/23), 1222043041 (Exp 4/20/23), 1222043042 (Exp 4/20/23), 1222043043 (Exp 4/21/23), 1222043044 (Exp 4/21/23);
• lots 1223041990 (Exp 5/3/23), 1223041991 (Exp 5/3/23), 1223041992 (Exp 5/5/23), 1223041993 (Exp 5/6/23), 1223041996 (Exp 5/11/23), 1223041997 (Exp 5/10/23), 1223041998 (Exp 5/11/23), 1223041999 (Exp 5/12/23), 1223042000 (Exp 5/12/23), 1223042001 (Exp 5/13/23), 1223042002 (Exp 5/16/23), 1223042003 (Exp 5/17/23), 1223042004 (Exp 5/21/23), 1223042006 (Exp 5/16/23), 1223042007 (Exp 5/6/23), 1223042008 (Exp 5/10/23), 1223042009 (Exp 5/5/23), 1223042010 (Exp 5/4/23), 1223042766 (Exp 5/18/23), 1223042767 (Exp 5/17/23), 1223042769 (Exp 5/18/23), 1223042770 (Exp 5/19/23), 1223042771 (Exp 5/19/23), 1223042772 (Exp 5/20/23), 1223042773 (Exp 5/21/23), 1223042774 (Exp 5/23/23), 1223042776 (Exp 5/23/23), 1223042777 (Exp 5/24/23), 1223042778 (Exp 5/24/23), 1223042783 (Exp 5/31/23);
• lots 1223042784 (Exp 6/1/23), 1223042785 (Exp 5/31/23), 1223042786 (Exp 6/1/23), 1223044081 (Exp 6/2/23), 1223044082 (Exp 6/2/23), 1223044117 (Exp 6/6/23), 1223044118 (Exp 6/6/23), 1223044143 (Exp 6/3/23), 1223044144 (Exp 6/3/23), 1223044166 (Exp 6/14/23), 1223044173 (Exp 6/7/23), 1223044191 (Exp 6/7/23), 1223044198 (Exp 6/8/23), 1223044220 (Exp 6/8/23), 1223044225 (Exp 6/13/23), 1223044247 (Exp 6/14/23), 1223044255 (Exp 6/14/23), 1223044267 (Exp 6/15/23), 1223044302 (Exp 6/15/23), 1223044311 (Exp 6/16/23), 1223044389 (Exp 6/24/23), 1223044523 (Exp 6/24/23), 1223044552 (Exp 6/28/23), 1223044582 (Exp 6/27/23), 1223044590 (Exp 6/27/23), 1223044629 (Exp 6/29/23), 1223044636 (Exp 6/29/23), 1223044656 (Exp 6/30/23), 1223044662 (Exp 6/30/23); and
• lots 1223044682 (Exp 7/1/23), 1223044687 (Exp 7/1/23), 1223044711 (Exp 7/5/23), 1223044741 (Exp 7/4/23), 1223044749 (Exp 7/4/23), 1223044774 (Exp 7/5/23), 1223044793 (Exp 7/6/23), and 1223044868 (Exp 7/8/23).

The affected products were distributed throughout the United States.

SCA Pharmaceuticals voluntarily initiated the recall April 10, 2023. The FDA designated the recall Class III on April 27, 2023, suggesting use of the recalled oxytocin is not likely to cause harm.

Oxytocin 30 units added to 0.9% sodium chloride is a compounded oxytocic agent used in labor and delivery and to control bleeding after childbirth.