Multi-event April 2013 FDA Recall Drug by Nuvision Pharmacy, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Nuvision Pharmacy, Inc. on April 15, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1052-2014 TERMINATED D-1051-2014 TERMINATED

Recall Number: D-1052-2014

Reason for Recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Initiated
04-15-2013
Reported
02-05-2014
Quantity
122 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64922
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.
NuVision Pharmacy, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244

Batch or Lot Expiration Information

Lot# :N10172012@11, Exp 10/17/2013

Recall Number: D-1051-2014

Reason for Recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Initiated
04-15-2013
Reported
02-05-2014
Quantity
285 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64922
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.
NuVision Pharmacy, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-08-2017
Product Description About Product Description
Full technical description of the product.
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Batch or Lot Expiration Information

Lot# s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15