Recalls / Class II
Class IID-0719-2023
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
- Affected lot / code info
- Lot # 37-883198, 37-883202, 37-883203, 37-883204, Exp 04/30/2023; 37-883799, Exp 05/02/2023; 37-884159, Exp 05/03/2023; 37-884888, 37-884892, 37-884899, 37-884901, Exp 05/07/2023; 37-886836, 37-886855, 37-886861, Exp 05/15/2023; 37-887381, Exp 05/16/2023; 37-887664, Exp 05/17/2023; 37-888256, 37-888259, 37-888267, Exp 05/21/2023; 37-888624, 37-888625, Exp 05/22/2023; 37-890038, 37-890041, 37-890042, Exp 05/28/2023; 37-890331, 37-890336, 37-890350, Exp 05/29/2023; 37-891163, Exp 05/31/2023; 37-892008, 37-892012, 37-892015, Exp 06/05/2023; 37-892882, 37-892884, Exp 06/07/2023
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
- 13772 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-0719-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.