Why it was recalled
Subpotent Drug: Out of specification results for low potency was obtained.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0555-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 10, 2023
- FDA report date
- May 3, 2023
- Quantity
- 73,312 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0555-2023, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 92073
- Address
- 755 Rainbow Rd Ste B
- 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
- Postal code
- 06095-1024
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0555-2023
- Classification
- Class III
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 73,312 containers
- Termination date
- Sep 20, 2023
- Reason for recall
- Subpotent Drug: Out of specification results for low potency was obtained.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2023