Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals Oxytocin Injection Bags Recalled for Low Potency

Agency Publication Date: April 27, 2023

Summary

SCA Pharmaceuticals has voluntarily recalled 73,312 containers of Oxytocin (30 units added to 0.9% Sodium Chloride, 500 mL) because tests showed the medication was subpotent, meaning it did not meet the required strength standards. This prescription drug is used in healthcare settings as an injection to induce or improve labor. No incidents or injuries have been reported to date in connection with this recall.

Risk

A medication with low potency may not provide the intended therapeutic effect, which could potentially delay or complicate clinical procedures during labor or delivery where oxytocin is medically necessary.

What You Should Do

This recall affects Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL (NDC 70004-085-44) sold in single-dose containers under the SCA Pharmaceuticals brand.
Check the lot number and date printed on the medication bag or product label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Oxytocin 30 units added to 0.9% Sodium Chloride (500 mL)by SCA Pharmaceuticals

Variants: Single Dose Container, Rx Only

Lot Numbers (83):

1222043028 (Exp 04/11/23)

1222043029 (Exp 04/13/23)

1222043031 (Exp 04/12/23)

1222043032 (Exp 04/12/23)

1222043033 (Exp 04/13/23)

1222043034 (Exp 04/13/23)

1222043035 (Exp 04/14/23)

1222043036 (Exp 04/14/23)

1222043037 (Exp 04/18/23)

1222043038 (Exp 04/18/23)

1222043039 (Exp 04/19/23)

1222043040 (Exp 04/19/23)

1222043041 (Exp 04/20/23)

1222043042 (Exp 04/20/23)

1222043043 (Exp 04/21/23)

1222043044 (Exp 04/21/23)

1223041990 (Exp 05/03/23)

1223041991 (Exp 05/03/23)

1223041992 (Exp 05/05/23)

1223041993 (Exp 05/06/23)

1223041996 (Exp 05/11/23)

1223041997 (Exp 05/10/23)

1223041998 (Exp 05/11/23)

1223041999 (Exp 05/12/23)

1223042000 (Exp 05/12/23)

1223042001 (Exp 05/13/23)

1223042002 (Exp 05/16/23)

1223042003 (Exp 05/17/23)

1223042004 (Exp 05/21/23)

1223042006 (Exp 05/16/23)

1223042007 (Exp 05/06/23)

1223042008 (Exp 05/10/23)

1223042009 (Exp 05/05/23)

1223042010 (Exp 05/04/23)

1223042766 (Exp 05/18/23)

1223042767 (Exp 05/17/23)

1223042769 (Exp 05/18/23)

1223042770 (Exp 05/19/23)

1223042771 (Exp 05/19/23)

1223042772 (Exp 05/20/23)

1223042773 (Exp 05/21/23)

1223042774 (Exp 05/23/23)

1223042776 (Exp 05/23/23)

1223042777 (Exp 05/24/23)

1223042778 (Exp 05/24/23)

1223042783 (Exp 05/31/23)

1223042784 (Exp 06/01/23)

1223042785 (Exp 05/31/23)

1223042786 (Exp 06/01/23)

1223044081 (Exp 06/02/23)

NDC:

70004-085-44

Distributed to hospitals and healthcare facilities nationwide.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92073

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Sold By: Hospitals; Healthcare facilities

Manufactured In: United States

Units Affected: 73,312 containers

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL (NDC 70004-085-44) sold in single-dose containers under the SCA Pharmaceuticals brand.

Check the lot number and date printed on the medication bag or product label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Affected Products

Product: Oxytocin 30 units added to 0.9% Sodium Chloride (500 mL)by SCA Pharmaceuticals

Variants: Single Dose Container, Rx Only

Lot Numbers (83):

1222043028 (Exp 04/11/23)

1222043029 (Exp 04/13/23)

1222043031 (Exp 04/12/23)

1222043032 (Exp 04/12/23)

1222043033 (Exp 04/13/23)

1222043034 (Exp 04/13/23)

1222043035 (Exp 04/14/23)

1222043036 (Exp 04/14/23)

1222043037 (Exp 04/18/23)

1222043038 (Exp 04/18/23)

1222043039 (Exp 04/19/23)

1222043040 (Exp 04/19/23)

1222043041 (Exp 04/20/23)

1222043042 (Exp 04/20/23)

1222043043 (Exp 04/21/23)

1222043044 (Exp 04/21/23)

1223041990 (Exp 05/03/23)

1223041991 (Exp 05/03/23)

1223041992 (Exp 05/05/23)

1223041993 (Exp 05/06/23)

1223041996 (Exp 05/11/23)

1223041997 (Exp 05/10/23)

1223041998 (Exp 05/11/23)

1223041999 (Exp 05/12/23)

1223042000 (Exp 05/12/23)

1223042001 (Exp 05/13/23)

1223042002 (Exp 05/16/23)

1223042003 (Exp 05/17/23)

1223042004 (Exp 05/21/23)

1223042006 (Exp 05/16/23)

1223042007 (Exp 05/06/23)

1223042008 (Exp 05/10/23)

1223042009 (Exp 05/05/23)

1223042010 (Exp 05/04/23)

1223042766 (Exp 05/18/23)

1223042767 (Exp 05/17/23)

1223042769 (Exp 05/18/23)

1223042770 (Exp 05/19/23)

1223042771 (Exp 05/19/23)

1223042772 (Exp 05/20/23)

1223042773 (Exp 05/21/23)

1223042774 (Exp 05/23/23)

1223042776 (Exp 05/23/23)

1223042777 (Exp 05/24/23)

1223042778 (Exp 05/24/23)

1223042783 (Exp 05/31/23)

1223042784 (Exp 06/01/23)

1223042785 (Exp 05/31/23)

1223042786 (Exp 06/01/23)

1223044081 (Exp 06/02/23)

NDC:

70004-085-44

Distributed to hospitals and healthcare facilities nationwide.