D-0150-2020 Class II Terminated
FDA drug recall D-0150-2020 was initiated by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center on October 9, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; bags have potential to leak The recall status is terminated (terminated December 1, 2020). Affected quantity: 162 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- October 30, 2019
- Initiation Date
- October 9, 2019
- Termination Date
- December 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 bags
Product Description
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Reason for Recall
Lack of Assurance of Sterility; bags have potential to leak
Distribution Pattern
Nationwide.
Code Information
Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019