Medications & Supplements/Prescription Drugs

Advanced Compounding Solutions Injectable Drugs Recalled for Contamination Risk

Agency Publication Date: July 19, 2023

Summary

Advanced Compounding Solutions (New England Life Care, Inc.) is recalling various compounded injectable medications, including Succinylcholine Chloride, Phenylephrine HCl, Rocuronium Bromide, and Vancomycin HCl, because production areas may have been compromised during manufacturing. Approximately 1,284 units are affected by this recall, which were distributed nationwide to hospitals and healthcare facilities. No incidents or injuries have been reported to date.

Risk

The use of contaminated injectable drugs can lead to serious, life-threatening infections or other adverse health reactions in patients. Because these medications are administered directly into the bloodstream or muscle, any compromise in sterility poses a significant safety risk.

What You Should Do

This recall affects multiple compounded injectable medications produced by Advanced Compounding Solutions, including Succinylcholine Chloride syringes, Phenylephrine HCl IV bags, Rocuronium Bromide syringes, and Vancomycin HCl IV bags.
Identify affected products by checking the lot numbers and NDC codes on the labeling. Affected NDC codes include 71546-083-10, 71546-450-25, 71546-090-05, and 71546-310-50. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Healthcare facilities should immediately quarantine any remaining stock of the affected lots and notify any clinical staff who may have access to these medications.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe

Variants: 10 mL BD Syringe, 20 mg/mL

Lot Numbers:

20230524-23C29D (Exp 21SEP2023)

NDC:

71546-083-10

Rx Only; Quantity: 493 syringes

Product: PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag

Variants: 250 mL IV Bag, 10mg in 250mL

Lot Numbers:

20230524-6FBB77 (Exp 21OCT2023)

NDC:

71546-450-25

Rx Only; Quantity: 82 Bags

Product: ROcuronium Bromide 50 mg/5 mL (10 mg/mL), 5mL Syringe

Variants: 5mL Syringe, 10 mg/mL

Lot Numbers:

20230524-530F73 (Exp 21OCT2023)

NDC:

71546-090-05

Rx Only; Quantity: 500 Syringes

Product: Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag

Variants: 500 mL IV Bag, 1.5 g in 500 mL

Lot Numbers:

20230524-0113AB (Exp 22AUG2023)

NDC:

71546-310-50

Rx Only; Quantity: 209 Bags

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92690

Status: Resolved

Manufacturer: New England Life Care, Inc. dba Advanced Compounding Solutions

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 4 products (493 syringes; 82 Bags; 500 Syringes; 209 Bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple compounded injectable medications produced by Advanced Compounding Solutions, including Succinylcholine Chloride syringes, Phenylephrine HCl IV bags, Rocuronium Bromide syringes, and Vancomycin HCl IV bags.

Identify affected products by checking the lot numbers and NDC codes on the labeling. Affected NDC codes include 71546-083-10, 71546-450-25, 71546-090-05, and 71546-310-50. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Healthcare facilities should immediately quarantine any remaining stock of the affected lots and notify any clinical staff who may have access to these medications.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Affected Products

Product: SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe

Variants: 10 mL BD Syringe, 20 mg/mL

Lot Numbers:

20230524-23C29D (Exp 21SEP2023)

NDC:

71546-083-10

Rx Only; Quantity: 493 syringes

Product: PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag

Variants: 250 mL IV Bag, 10mg in 250mL

Lot Numbers:

20230524-6FBB77 (Exp 21OCT2023)

NDC:

71546-450-25

Rx Only; Quantity: 82 Bags

Product: ROcuronium Bromide 50 mg/5 mL (10 mg/mL), 5mL Syringe

Variants: 5mL Syringe, 10 mg/mL

Lot Numbers:

20230524-530F73 (Exp 21OCT2023)

NDC:

71546-090-05

Rx Only; Quantity: 500 Syringes

Product: Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag

Variants: 500 mL IV Bag, 1.5 g in 500 mL

Lot Numbers:

20230524-0113AB (Exp 22AUG2023)

NDC:

71546-310-50

Rx Only; Quantity: 209 Bags

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92690

Status: Resolved

Manufacturer: New England Life Care, Inc. dba Advanced Compounding Solutions

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 4 products (493 syringes; 82 Bags; 500 Syringes; 209 Bags)

Distributed To: Nationwide