Recalls / Class II
Class IID-1132-2023
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
- Affected lot / code info
- Lot# 36-260043, 36-260039, Exp 9/8/2023; 36-262220, Exp 9/10/2023; 36-262526, 36-262525, 36-262524, Exp 9/14/2023. ;
Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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
- 1,996 bags.
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-17
- FDA classified
- 2023-08-28
- Posted by FDA
- 2023-09-06
- Terminated
- 2025-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1132-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.