D-0968-2022 Class II Terminated
FDA drug recall D-0968-2022 was initiated by Nephron Sterile Compounding Center LLC on May 18, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 604080 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2022
- Initiation Date
- May 18, 2022
- Termination Date
- Aug 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 604080 syringes
Product Description
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lots: RC1050A, Exp. 5/30/2022; RC1051B, Exp. 6/6/2022; RC1053A, Exp. 6/27/2022; RC2001A, Exp. 7/19/2022; RC2002A, Exp. 8/13/2022; RC2003A, Exp. 8/28/2022; RC2004A, Exp. 9/8/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0968-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026