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Recall Observatory FDA recall evidence

Drug product

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.

D-0347-2019

November 29, 2018

Class I

Product summary

Firm
Advanced Pharma Inc.
Event
Event 81685
Status
Terminated
Classification
Class I
Quantity
225 syringes
Official record key
drug-enforcement:D-0347-2019

Official wording

Reason: 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".

Code information: Lot: 11/01/18 8847 80261S, BUD: 03/31/19

Distribution pattern: Heath care facilities in NM, TX, and OH

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error