fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
- 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:
- Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Product Codes/Lot Numbers:
Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
Distribution:
Distributed in: TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0889-2018
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