D-0895-2018 Class II Terminated
FDA drug recall D-0895-2018 was initiated by SCA Pharmaceuticals, LLC on Jun 14, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. The recall status is terminated (terminated Feb 4, 2019). Affected quantity: 492 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 11, 2018
- Initiation Date
- Jun 14, 2018
- Termination Date
- Feb 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 492 bags
Product Description
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Reason for Recall
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0895-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026