Status
Terminated
Drug Enforcement D-0396-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
April 3, 2024
Termination Date
August 27, 2024
Product Information
- Product description
- fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
- Product quantity
- 500 bags
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- SCA Pharmaceuticals, LLC
- Address
-
755 Rainbow Rd Ste B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0396-2024
- Event ID
- 93456
- Recall initiation date
- November 9, 2023
- Center classification date
- March 22, 2024
- Code info
- Lot #: 1223048351, Exp 11/30/23; 1223048532, Exp 12/07/23
- More code info
- —