Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
Lot numbers, UPCs & expiration codes
Lot: 36-239496, Exp. 7/12/2023; 36-240256, Exp. 7/17/2023; 36-241134, Exp. 7/19/2023; 36-241928, Exp. 7/23/2023; 36-243835, Exp. 7/31/2023; 36-245010, 36-245011, Exp. 8/1/2023; 36-245529, 36-245532, Exp. 8/2/2023; 36-246255, 36-246256, 36-246258, 36-246259, Exp. 8/3/2023; 36-247806, Exp. 8/9/2023; 36-248035, Exp. 8/10/2023; 36-248367, Exp. 8/11/2023; 36-249506, 36-249507, 36-249508, Exp. 8/18/2023; 36-251436, 36-251437, Exp. 8/28/2023; 36-254396, Exp. 9/4/2023
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-0976-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 6037 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0976-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92707
- Address
- 2200 S 43rd Ave
- Code information
- Lot: 36-239496, Exp. 7/12/2023; 36-240256, Exp. 7/17/2023; 36-241134, Exp. 7/19/2023; 36-241928, Exp. 7/23/2023; 36-243835, Exp. 7/31/2023; 36-245010, 36-245011, Exp. 8/1/2023; 36-245529, 36-245532, Exp. 8/2/2023; 36-246255, 36-246256, 36-246258, 36-246259, Exp. 8/3/2023; 36-247806, Exp. 8/9/2023; 36-248035, Exp. 8/10/2023; 36-248367, Exp. 8/11/2023; 36-249506, 36-249507, 36-249508, Exp. 8/18/2023; 36-251436, 36-251437, Exp. 8/28/2023; 36-254396, Exp. 9/4/2023
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-0976-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 6037 bags
- Termination date
- Mar 28, 2025
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023