Recalls / Class II
Class IID-0716-2023
Product
potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.
- Affected lot / code info
- Lot # 37-883769, Exp 05/02/2023; 37-884449, Exp 05/04/2023; 37-885585, Exp 05/09/2023; 37-885922, Exp 05/10/2023; 37-886526, Exp 05/14/2023; 37-887387, Exp 05/16/2023; 37-887659, 37-887662, Exp 05/17/2023; 37-889064, Exp 05/23/2023; 37-889735, 37-889745, Exp 05/25/2023; 37-890036, 37-890055, Exp 05/28/2023; 37-890934, Exp 05/30/2023; 37-892890, Exp 06/07/2023; 37-893813, Exp 06/12/2023; 37-894317, Exp 06/13/2023; 37-895275, Exp 06/18/2023; 37-896822, 37-896852, Exp 06/22/2023; 37-897826, 37-897839, Exp 06/27/2023
Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6580 Snowdrift Rd Ste 100, N/A, Allentown, Pennsylvania 18106-9331
Distribution
- Quantity
- 9432 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-04-28
- FDA classified
- 2023-05-19
- Posted by FDA
- 2023-05-31
- Terminated
- 2025-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0716-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.