Multi-event August 2015 FDA Recall Drug by Nephron Pharmaceuticals Corp.

This Multi-event Class II drug recall was voluntarily initiated by Nephron Pharmaceuticals Corp. on August 21, 2015 for the product Drug. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0388-2016 TERMINATED D-0389-2016 TERMINATED

Recall Number: D-0388-2016

Reason for Recall
Discoloration
Initiated
08-21-2015
Reported
12-09-2015
Quantity
47,754 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72102
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.
Nephron Pharmaceuticals Corp.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2017
Product Description About Product Description
Full technical description of the product.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

Batch or Lot Expiration Information

Lot# Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)

Recall Number: D-0389-2016

Reason for Recall
Discoloration
Initiated
08-21-2015
Reported
12-09-2015
Quantity
32,490 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72102
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.
Nephron Pharmaceuticals Corp.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2017
Product Description About Product Description
Full technical description of the product.
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01

Batch or Lot Expiration Information

Lot# Lots R4016A (Exp 08/31/2015), R4017A (Exp 08/31/2015), R4035A (Exp 12/31/2015)