D-0188-2021 Class II Terminated
FDA drug recall D-0188-2021 was initiated by SCA Pharmaceuticals on December 17, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit The recall status is terminated (terminated November 2, 2021). Affected quantity: 1,879 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 13, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,879 syringes
Product Description
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Distribution Pattern
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023041, BUD 1/20/2021; 1220023188, BUD 1/27/2021 & 1220023397, BUD 2/3/2021.