Status
Terminated
Drug Enforcement D-0654-2023
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Report Date
May 31, 2023
Termination Date
June 22, 2025
Product Information
- Product description
- Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
- Product quantity
- 254 bags
- Reason for recall
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
6580 Snowdrift Rd Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0654-2023
- Event ID
- 92253
- Recall initiation date
- April 28, 2023
- Center classification date
- May 19, 2023
- Code info
- Lot # 37-893848, Exp 04/28/2023; 37-895681, Exp 05/05/2023; 37-899250, Exp 05/19/2023; 37-901355, Exp 05/27/2023
- More code info
- —