Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as
Advanced Pharma recalls Phenylephrine HCl 1mg in Sterile Water for Injection, 10mL solution due to incorrect labeling of concentration. This error could lead to improper dosing if used without proper understanding.
Lower-risk recall
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Contact the company & request your remedy
What happened, in plain English
Advanced Pharma has recalled a specific phenylephrine solution product because its label incorrectly states the concentration as 10 mcg per mL instead of the correct 100 mcg per mL. This labeling error could lead to incorrect dosing if the product is used without understanding the proper concentration. Read more at govinfonow.com/recall/39401-advanced-pharma-recalls-phenylephrine-hcl-1mg-solution-due-to-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/39401-advanced-pharma-recalls-phenylephrine-hcl-1mg-solution-due-to-labeling · Updated October 5, 2026 · FDA enforcement record: FDA #D-0347-2019
Cite this page
“Advanced Pharma Recalls Phenylephrine HCl 1mg Solution Due to Labeling Error.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39401-advanced-pharma-recalls-phenylephrine-hcl-1mg-solution-due-to-labeling. Based on FDA recall #D-0347-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2019%22&limit=1).
Why it’s dangerous
The product is labeled with an incorrect concentration (10 mcg per mL instead of 100 mcg per mL). This error could lead to underdosing if the product is used without understanding the correct concentration, potentially affecting treatment effectiveness.
Who’s affected
This recall affects healthcare professionals and patients who have the specific phenylephrine solution product with the incorrect labeling. Those using the product for medical purposes are most at risk due to potential dosing errors.
How to tell if you have this one
Check for the product name 'Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL' with the incorrect label stating '10 mcg per mL'. The product was sold by Advanced Pharma in Houston, TX with NDC 42852-802-61 and lot number 8847 80261S.
- Brand
Advanced Pharma- Category
Drug
What to do — step by step
Check Label
Verify the concentration listed on the label; it should state '100 mcg per mL' not '10 mcg per mL'.
Questions people ask
Is this product safe to use?
The product is not safe to use as labeled due to the concentration error. It should be checked for the correct concentration before use.
How can I tell if I have the recalled product?
Look for the product name 'Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL' with the label stating '10 mcg per mL' instead of '100 mcg per mL'.
What should I do if I have the recalled product?
The recall does not specify a remedy, so check the label for the correct concentration before use. If the label is incorrect, contact Advanced Pharma at (877) 794-0404.
Contact Advanced Pharma
We’ve drafted a message you can send Advanced Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0347-2019 — Advanced Pharma Advanced Pharma Hello, I own a Advanced Pharma that is covered by recall D-0347-2019 from Advanced Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0347-2019 (November 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0347-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.