February 2019 FDA Recall Drug by Advanced Pharma Inc.
D-0496-2019 - Labeling

This Class II drug recall was voluntarily initiated by Advanced Pharma Inc. on February 6, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in PA and the recall is currently terminated.

Recall Number: D-0496-2019

Reason for Recall
Labeling: Incorrect expiration date.
Initiated
02-06-2019
Reported
02-27-2019
Quantity
100 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82130
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-30-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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