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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is potential manufacturing environment contamination, not confirmed product contamination, constituting a precautionary recall.
Plain-English summary
New England Life Care, Inc. dba Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl 10mg in 0.9% Sodium Chloride 250mL intravenous solution (Lot #20230524-6FBB77, NDC 71546-450-25). The recall was initiated due to violations of current Good Manufacturing Practice (CGMP). Specifically, spaces adjacent to the production area may have been compromised at the time of manufacture.
The recalled product was distributed nationwide in the USA with an expiration date of October 21, 2023.
No illnesses or injuries have been reported in connection with this product. Patients currently using this medication should contact their healthcare provider or pharmacist for guidance on continued use or replacement.
The recalled product
- 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
- Drug — Injectable / IV Solution
- Affected units
- 82
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 # 20230524-6FBB77
- Exp 21OCT2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by New England Life Care, Inc. dba Advanced Compounding Solutions under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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