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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: 11/01/18 8847 80261S, BUD: 03/31/19
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Advanced Pharma Inc.
- Reason for 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".
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot: 11/01/18 8847 80261S, BUD: 03/31/19
Distribution:
Distributed in: NM, TX, OH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0347-2019
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