June 2018 FDA Recall Drug by Advanced Pharma Inc.
D-0889-2018 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Advanced Pharma Inc. on June 20, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in Distributed to one medical center in Fort Worth, TX. and the recall is currently terminated.

Recall Number: D-0889-2018

Reason for Recall
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Initiated
06-20-2018
Reported
07-04-2018
Quantity
100 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80354
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to one medical center in Fort Worth, TX.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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