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Recall Observatory FDA recall evidence

Drug product

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.

D-0889-2018

June 20, 2018

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 80354
Status
Terminated
Classification
Class II
Quantity
100 syringes
Official record key
drug-enforcement:D-0889-2018

Official wording

Reason: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.

Code information: Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18

Distribution pattern: Distributed to one medical center in Fort Worth, TX.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent