Status
Terminated
Drug Enforcement D-0407-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
April 3, 2024
Termination Date
August 27, 2024
Product Information
- Product description
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
- Product quantity
- 1,023 syringes
- 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-0407-2024
- Event ID
- 93456
- Recall initiation date
- November 9, 2023
- Center classification date
- March 22, 2024
- Code info
- Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24
- More code info
- —