Recalls / Class II
Class IID-0722-2023
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
- Affected lot / code info
- Lot # 37-883390, 37-883435, Exp 05/01/2023; 37-884157, Exp 05/03/2023; 37-885716, 37-886036, 37-886039, Exp 05/09/2023; 37-887499, 37-887500, Exp 05/16/2023; 37-887778, Exp 05/17/2023; 37-888105, Exp 05/18/2023; 37-889216, Exp 05/23/2023; 37-890923, 37-890928, 37-890936, Exp 05/30/2023; 37-891271, Exp 05/31/2023; 37-892649, Exp 06/06/2023; 37-892962, Exp 06/07/2023; 37-893966, 37-893967, 37-893969, 37-893998, Exp 06/12/2023; 37-896160, 37-896162, 37-896171, Exp 06/20/2023
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
- 9037 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-0722-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.