Recalls / Class II
Class IID-0954-2023
Product
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
- Affected lot / code info
- Lot: 36-239250, Exp. 7/10/2023; 36-240225, Exp.7/16/2023; 36-241268, 36-241270, Exp. 7/19/2023; 36-241443, Exp. 7/20/2023; 36-242436, 36-242439, Exp. 7/25/2023; 36-241443, Exp. 7/20/2023; 36-242436, 36-242439, Exp. 7/25/2023; 36-243517, 36-243738, Exp. 7/30/2023; 36-245656, Exp. 8/2/2023; 36-246154, 36-246169, 36-246672, 36-246673, 36-246674, Exp. 8/3/2023; 36-247015, 36-247016, 36-247017, Exp. 8/7/2023; 36-247339, 36-247341, 36-247342, 36-247343, Exp. 8/8/2023; 36-249466, 36-249467, Exp. 8/17/2023; 36-249591, 36-249592, Exp. 8/18/2023; 36-251338, Exp. 8/27/2023; 36-251940, Exp. 8/30/2023; 36-254371, 36-254372, 36-254373, 36-254375, 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
- 9,121 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-0954-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.