Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharm...
FDA Recall #D-0555-2023 — Class III — April 10, 2023
Product Description
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Reason for Recall
Subpotent Drug: Out of specification results for low potency was obtained.
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
73,312 containers
Distribution
Nationwide in the USA
Code Information
Lot # 1222043028 04/11/23 1222043029 04/13/23 1222043031 04/12/23 1222043032 04/12/23 1222043033 04/13/23 1222043034 04/13/23 1222043035 04/14/23 1222043036 04/14/23 1222043037 04/18/23 1222043038 04/18/23 1222043039 04/19/23 1222043040 04/19/23 1222043041 04/20/23 1222043042 04/20/23 1222043043 04/21/23 1222043044 04/21/23 1223041990 05/03/23 1223041991 05/03/23 1223041992 05/05/23 1223041993 05/06/23 1223041996 05/11/23 1223041997 05/10/23 1223041998 05/11/23 1223041999 05/12/23 1223042000 05/12/23 1223042001 05/13/23 1223042002 05/16/23 1223042003 05/17/23 1223042004 05/21/23 1223042006 05/16/23 1223042007 05/06/23 1223042008 05/10/23 1223042009 05/05/23 1223042010 05/04/23 1223042766 05/18/23 1223042767 05/17/23 1223042769 05/18/23 1223042770 05/19/23 1223042771 05/19/23 1223042772 05/20/23 1223042773 05/21/23 1223042774 05/23/23 1223042776 05/23/23 1223042777 05/24/23 1223042778 05/24/23 1223042783 05/31/23 1223042784 06/01/23 1223042785 05/31/23 1223042786 06/01/23 1223044081 06/02/23 1223044082 06/02/23 1223044117 06/06/23 1223044118 06/06/23 1223044143 06/03/23 1223044144 06/03/23 1223044166 06/14/23 1223044173 06/07/23 1223044191 06/07/23 1223044198 06/08/23 1223044220 06/08/23 1223044225 06/13/23 1223044247 06/14/23 1223044255 06/14/23 1223044267 06/15/23 1223044302 06/15/23 1223044311 06/16/23 1223044389 06/24/23 1223044523 06/24/23 1223044552 06/28/23 1223044582 06/27/23 1223044590 06/27/23 1223044629 06/29/23 1223044636 06/29/23 1223044656 06/30/23 1223044662 06/30/23 1223044682 07/01/23 1223044687 07/01/23 1223044711 07/05/23 1223044741 07/04/23 1223044749 07/04/23 1223044774 07/05/23 1223044793 07/06/23 1223044868 07/08/23
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated