D-0926-2023 Class II Terminated
FDA drug recall D-0926-2023 was initiated by New England Life Care, Inc. dba Advanced Compounding Solutions on July 10, 2023 and is designated Class II. Reason for recall: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. The recall status is terminated (terminated December 4, 2023). Affected quantity: 493 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 26, 2023
- Initiation Date
- July 10, 2023
- Termination Date
- December 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 493 syringes
Product Description
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
Reason for Recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 20230524-23C29D, Exp 21SEP2023