Multi-event May 2014 FDA Recall Drug by Central Admixture Pharmacy Services, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Central Admixture Pharmacy Services, Inc. on May 28, 2014 for the product Drug. The FDA reported the reason for recall as non sterility; microbial contamination identified as aspergillus species. The product was distributed in Michigan and Wisconsin and the recall is currently terminated.

Reported Recall Events

D-1560-2014 TERMINATED D-1561-2014 TERMINATED D-1559-2014 TERMINATED D-1562-2014 TERMINATED

Recall Number: D-1560-2014

Reason for Recall
Non Sterility; microbial contamination identified as Aspergillus species
Initiated
05-28-2014
Reported
09-03-2014
Quantity
31 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68532
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.
Central Admixture Pharmacy Services, 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.
Michigan and Wisconsin
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2014
Product Description About Product Description
Full technical description of the product.
del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Batch or Lot Expiration Information

Lot# 13-920742-0-1 EXP 21 JUN 2014 and
Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014

Recall Number: D-1561-2014

Reason for Recall
Non Sterility; microbial contamination identified as Aspergillus species
Initiated
05-28-2014
Reported
09-03-2014
Quantity
5 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68532
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.
Central Admixture Pharmacy Services, 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.
Michigan and Wisconsin
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2014
Product Description About Product Description
Full technical description of the product.
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Batch or Lot Expiration Information

Lot# 13-920757-0-1 through
Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 2014

Recall Number: D-1559-2014

Reason for Recall
Non Sterility; microbial contamination identified as Aspergillus species
Initiated
05-28-2014
Reported
09-03-2014
Quantity
1 dose

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68532
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.
Central Admixture Pharmacy Services, 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.
Michigan and Wisconsin
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2014
Product Description About Product Description
Full technical description of the product.
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Batch or Lot Expiration Information

Lot# 13-920741-0-1 EXP 21 JUN 2014

Recall Number: D-1562-2014

Reason for Recall
Non Sterility; microbial contamination identified as Aspergillus species
Initiated
05-28-2014
Reported
09-03-2014
Quantity
4 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68532
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.
Central Admixture Pharmacy Services, 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.
Michigan and Wisconsin
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2014
Product Description About Product Description
Full technical description of the product.
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Batch or Lot Expiration Information

Lot# 13-920739-01 through
Lot# 13-920739-04 (4 total doses) EXP 21 Jun 2014