The Recall Desk

FDA (Drugs) recall action 92690

New England Life Care, Inc. dba Advanced Compounding Solutions recalled 4 products on 2023-07-26

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2023-07-26
Critical
0
Units
1,284

Why these products were recalled

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Drugs)··2023-07-26

    Vancomycin IV Bags Recalled Due to Manufacturing Environment Contamination Risk

    New England Life Care is recalling Vancomycin HCl IV bags due to potential CGMP violations that may have compromised the production environment. The recall affects 209 bags distributed nationwide.

    Product
    Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Succinylcholine Chloride Injectable Drug Recalled Nationwide for Manufacturing Facility Contamination Risk

    Advanced Compounding Solutions is recalling 493 syringes of succinylcholine chloride injection due to potential contamination from manufacturing facility violations affecting product sterility.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Rocuronium Bromide Injectable Recalled Due to CGMP Violations

    Advanced Compounding Solutions is recalling Rocuronium Bromide 10 mg/mL injectables (lot #20230524-530F73) nationwide due to CGMP violations. Production spaces adjacent to the manufacturing area may have been compromised.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-07-26

    FDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination

    Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl intravenous solution due to potential contamination from manufacturing facility violations. No illnesses have been reported.

    Product
    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;
    Category
    Distribution
    0 states