Recalls / Class II
Class IID-0976-2023
Product
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
- Affected lot / code info
- 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
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 6037 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0976-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.