Multi-event September 2013 FDA Recall Drug by University Compounding Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by University Compounding Pharmacy on September 6, 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
Recall Number: D-1021-2013
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
09-06-2013
09-18-2013
965.50 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
University Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Batch or Lot Expiration Information
Lot# s: 474323, Exp 9/13/2013; 498616, Exp 9/25/2013; 475475, Exp 9/26/2013.
Recall Number: D-1022-2013
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
09-06-2013
09-18-2013
70 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
University Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Batch or Lot Expiration Information
Lot# Lot 513593, Exp11/30/2013
Recall Number: D-1020-2013
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
09-06-2013
09-18-2013
178.2 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
University Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Batch or Lot Expiration Information
Lot# Lot 511017, Exp 11/30/2013
Recall Number: D-1024-2013
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
09-06-2013
09-18-2013
37.805 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
University Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
Batch or Lot Expiration Information
Lot# : 497930, 11/5/2013
Recall Number: D-1023-2013
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
09-06-2013
09-18-2013
85 mL
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
University Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
01-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
Batch or Lot Expiration Information
Lot# : 497940, Exp 9/6/2013
