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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for injectable medication due to potential CGMP violations and compromised production environment. No reported illnesses or injuries. Per the rubric, theoretical hazards without reported illness score at most 3 (High), though the risk-of-harm nature of compounded injectables supports this severity level.
Plain-English summary
New England Life Care, Inc. (dba Advanced Compounding Solutions) is recalling Vancomycin HCl 1.5 g in 0.9% Sodium Chloride 500 mL IV bags (NDC 71546-310-50) due to manufacturing violations.
The recall was issued because spaces adjacent to the production area may have been compromised at the time of production, creating a potential risk that the product may not meet current Good Manufacturing Practice (CGMP) standards.
The affected product is lot number 20230524-0113AB with an expiration date of August 22, 2023. A total of 209 bags were distributed nationwide to healthcare facilities.
Healthcare facilities and patients who have received this product should contact the manufacturer or their healthcare provider immediately. Do not use the product. Return any remaining product to the manufacturer or dispose of it according to applicable regulations.
The recalled product
- 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;
- Manufacturer
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Category
- Drug — Injectable Medication
- Hazard
- cgmp-violation
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20230524-0113AB
- Exp 22AUG2023
Distribution
Distributed nationwide across the United States.
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