Multi-event July 2014 FDA Recall Drug by Unique Pharmaceutical, Ltd

This Multi-event Class II drug recall was voluntarily initiated by Unique Pharmaceutical, Ltd on July 18, 2014 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0012-2015 TERMINATED D-0011-2015 TERMINATED

Recall Number: D-0012-2015

Reason for Recall
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Initiated
07-18-2014
Reported
10-15-2014
Quantity
325,225 units (syringes, vials, bags)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68841
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.
Unique Pharmaceutical, Ltd
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-24-2016
Product Description About Product Description
Full technical description of the product.
All sterile products within expiry

Batch or Lot Expiration Information

Lot# All Lots

Recall Number: D-0011-2015

Reason for Recall
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Initiated
07-18-2014
Reported
10-15-2014
Quantity
3,529 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68841
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.
Unique Pharmaceutical, Ltd
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-24-2016
Product Description About Product Description
Full technical description of the product.
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

Batch or Lot Expiration Information

Lot# : 86513, Exp 07/23/2014