Class III — the FDA judged the product is unlikely to cause harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Subpotent Drug: Out of specification results for low potency was obtained.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / 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
Recall status
Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.
Where it was distributed
Nationwide in the USA
Recall record
- Recalling firm
- SCA Pharmaceuticals
- Product type
- Drugs
- Recall number
- D-0555-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Windsor, CT
- Recall initiated
- 2023-04-10
- Terminated
- 2023-09-20
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall D-0555-2023 · Source: openFDA enforcement.