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.
Reported: July 4, 2018 Initiated: June 20, 2018 #D-0889-2018
Product 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.
Reason for Recall
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Details
- Recalling Firm
- Advanced Pharma Inc.
- Units Affected
- 100 syringes
- Distribution
- Distributed to one medical center in Fort Worth, TX.
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Advanced Pharma Inc.. Units affected: 100 syringes.
Why was this product recalled? ▼
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 4, 2018. Severity: Moderate. Recall number: D-0889-2018.
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