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Recall Observatory FDA recall evidence

Drug product

Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72

D-0496-2019

February 06, 2019

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 82130
Status
Terminated
Classification
Class II
Quantity
100 syringes
Official record key
drug-enforcement:D-0496-2019

Official wording

Reason: Labeling: Incorrect expiration date.

Code information: Lot#: 12/31/18 0555 21072S, Exp 3/31/2019

Distribution pattern: PA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect