ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste
New England Life Care, Inc. dba Advanced Compounding Solutions
Summary
The FDA issued a Class II for ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compou by New England Life Care, Inc. dba Advanced Compounding Solutions. Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production..
Details
Source
Drug Recall
External ID
D-0928-2023
Action Date
2023-07-26
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 20230524-530F73, Exp 21OCT2023
Quantity Affected: 500 Syringes
Reason for Recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-10
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 71 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
New England Life Care, Inc. dba Advanced Compounding Solutions has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New England Life Care, Inc. dba Advanced Compounding Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New England Life Care, Inc. dba Advanced Compounding Solutions have FDA actions?
New England Life Care, Inc. dba Advanced Compounding Solutions has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0928-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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