Recalls / Class II
Class IID-0961-2023
Product
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
- Affected lot / code info
- Lot:36-239194, 36-239195, Exp.7/10/2023; 36-240009, Exp. 7/13/2023; 36-240799, Exp.7/17/2023; 36-241147, 36-241148, Exp. 7/19/2023; 36-241740, 36-241741, Exp. 7/21/2023; 36-242562, Exp. 7/25/2023; 36-243531, Exp. 7/30/2023; 36-244886, 36-244961, Exp. 8/1/2023; 36-246713, 36-246714, 36-24671, 536-246716, Exp. 8/6/2023; 36-247344, 36-247345, 36-247347, 36-247348, 36-247349, 36-247350, Exp. 8/8/2023; 36-247823, 36-247824, 36-247825, 36-247826, Exp. 8/10/2023; 36-248356, 36-248358, Exp. 8/11/2023; 36-249226, Exp. 8/17/2023; 36-251966, Exp. 8/30/2023.
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
- 8,363 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-0961-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.