November 2018 FDA Recall Drug by Advanced Pharma Inc.
D-0347-2019 - Labeling

This Class I drug recall was voluntarily initiated by Advanced Pharma Inc. on November 29, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Heath care facilities in NM, TX, and OH and the recall is currently terminated.

Recall Number: D-0347-2019

Reason for Recall
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".
Initiated
11-29-2018
Reported
01-02-2019
Quantity
225 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81685
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Heath care facilities in NM, TX, and OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-02-2019
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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