Home / Recalls / New England Life Care, Inc. dba Advanced Compounding Solutions / D-0928-2023

D-0928-2023 Class II Terminated

Recalled by New England Life Care, Inc. dba Advanced Compounding Solutions — Woburn, MA

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
500 Syringes

Product Description

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

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 # 20230524-530F73, Exp 21OCT2023

Other recalls by New England Life Care, Inc. dba Advanced Compounding Solutions

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  • D-0926-2023 Class II — SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Adva (July 10, 2023)
  • D-0927-2023 Class II — PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 To (July 10, 2023)
  • D-0778-2023 Class III — Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compou (May 22, 2023)