FDAFDA · Food and drugs·Recall number D-0347-2019
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.
Published January 2, 2019 · Recall initiated: November 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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".
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Advanced Pharma Inc.
- Distributor
- Heath care facilities in NM, TX, and OH
- Lot
- Lot: 11/01/18 8847 80261S, BUD: 03/31/19
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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