Recalls / Class II
Class IID-0721-2023
Product
vancomycin added to dextrose 5%, 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 71285-6075-1.
- Affected lot / code info
- Lot # 37-883196, 37-883197, 37-883205, Exp 04/30/2023; 37-884882, 37-884890, 37-884898, Exp 05/07/2023; 37-886840, 37-886858, 37-886863, Exp 05/15/2023; 37-887365, Exp 05/16/2023; 37-887663, Exp 05/17/2023; 37-888254, 37-888257, 37-888265, 37-888303, Exp 05/21/2023; 37-889453, Exp 05/24/2023; 37-890037, 37-890039, 37-890043, Exp 05/28/2023; 37-890330, 37-890333, 37-890344, Exp 05/29/2023; 37-892009, 37-892011, 37-892016, Exp 06/05/2023; 37-892881, Exp 06/07/2023; 37-893448, Exp 06/11/2023; 37-895221, Exp 06/18/2023; 37-898530, Exp 06/29/2023
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
- 10282 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-0721-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.