Home / Recalls / New England Life Care, Inc. dba Advanced Compounding Solutions / D-0927-2023

D-0927-2023 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
82 Bags

Product Description

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

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 # 20230524-6FBB77, Exp 21OCT2023

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

  • D-0929-2023 Class II — Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 to (July 10, 2023)
  • D-0926-2023 Class II — SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Adva (July 10, 2023)
  • D-0928-2023 Class II — ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compou (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)