Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Phenylephrine HCl Recalled by Advanced Pharma Inc. Due to Labeling: Label Error on Declared Strength: Label incorrectly...

Date: November 29, 2018
Company: Advanced Pharma Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Pharma Inc. directly.

Affected Products

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.

Quantity: 225 syringes

Why Was This Recalled?

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".

Where Was This Sold?

This product was distributed to 3 states: NM, OH, TX

Affected (3 states)Not affected

About Advanced Pharma Inc.

Advanced Pharma Inc. has 99 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report