Recalls / Class II
Class IID-0755-2023
Product
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
- Affected lot / code info
- Lot # 37-885553, 37-885554, Exp 05/09/2023; 37-887923, 37-887924, Exp 05/18/2023; 37-890778, 37-890779, Exp 05/30/2023; 37-892847, Exp 06/07/2023; 37-895049, Exp 06/15/2023; 37-898480, 37-898481, 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
- 1673 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-0755-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.