Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Medicine recall D-0555-2023. Published in FDA’s Enforcement Report on May 3, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 3, 2023. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 73,312 containers how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Subpotent Drug: Out of specification results for low potency was obtained.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
73,312 containers, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,665 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
70004-085-44
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide in the USA
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 10, 2023.
- FDA classified it on Apr 27, 2023.
- FDA’s Enforcement Report published it on May 3, 2023.
- FDA terminated it on Sep 20, 2023.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SCA Pharmaceuticals, of Windsor, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.