Multi-event December 2013 FDA Recall Drug by Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
This Multi-event Class II drug recall was voluntarily initiated by Zions Rx Formulations Services Llc Dba Rx Formuations Serv. on December 12, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in AZ and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1217-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
610 units
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# a)
Lot# : 117460@5 Expiration Date: 12/12/2013
Lot# : 117911@5 Expiration Date: 12/19/2013
Lot# : 118301@9 Expiration Date: 12/25/2013 b)
Lot# : 117462@6 Expiration Date: 12/12/2013
Lot# : 117916@6 Expiration Date: 12/19/2013
Lot# : 118305@10 Expiration Date: 12/25/2013 c)
Lot# : 118011@23 Expiration Date: 12/18/2013
Lot# : 118092@63 Expiration Date: 12/18/2013
Lot# : 118401@31 Expiration Date: 12/25/2013
Lot# : 118013@24 Expiration Date: 12/18/2013
Lot# : 118094@64 Expiration Date: 12/18/2013
Lot# : 118403@32 Expiration Date: 12/25/2013
Recall Number: D-1213-2014
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
12-12-2013
04-16-2014
450 Vials
Recall Profile & Regulatory Data
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.
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
Batch or Lot Expiration Information
Lot# : 117433@15 Expiration Date: 12/07/2013
Lot# : 117446@8 Expiration Date: 12/12/2013
Lot# : 117923@8 Expiration Date: 12/19/2013
Recall Number: D-1219-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
38 units
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# a)
Lot# 118954@2 Exp. Date: 03/09/2014
Lot# 118917@2 Exp. Date: 03/06/2014; b)
Lot# : 119379@24 Exp. Date: 01/19/2014
Lot# : 118815@27 Exp. Date: 03/03/2014
Recall Number: D-1214-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
861 Bags
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# : 117037@3 Expiration Date: 12/13/2013
Lot# : 117899@1 Expiration Date: 01/03/2014
Lot# : 118289@7 Expiration Date: 01/09/2014
Lot# : 118078@56 Expiration Date: 01/03/2014
Lot# :118394@29 Expiration Date: 01/09/2014
Lot# : 118338@10 Expiration Date: 01/09/2014
Lot# : 118056@46 Expiration Date: 01/02/2014
Recall Number: D-1215-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
95 Vials
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# : 117467@9 Expiration Date: 12/12/2013
Lot# : 117857@2 Expiration Date: 12/15/2013
Lot# : 117740@4 Expiration Date: 12/13/2013
Recall Number: D-1216-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
1,495 Bags
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# : 117440@1 Expiration Date: 12/27/2013
Lot# : 117901@2 Expiration Date: 01/03/2014
Lot# : 118291@32 Expiration Date: 01/05/2014
Lot# : 118392@28 Expiration Date: 01/09/2014
Lot# : 117659@66 Expiration Date: 12/26/2013
Lot# : 118348@17 Expiration Date: 01/09/2014
Lot# : 117601@38 Expiration Date: 12/26/2013
Lot# : 117847@13 Expiration Date: 12/29/2013
Lot# : 118058@47 Expiration Date: 01/02/2014
Recall Number: D-1218-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
12-12-2013
04-16-2014
60 units
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.
Zions RX Formulations Services LLC dba RX Formuations Serv.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ
05-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Batch or Lot Expiration Information
Lot# : 117456@3 Expiration Date: 12/12/2013
Lot# : 117907@3 Expiration Date: 12/19/2013
Lot# : 118297@8 Expiration Date: 12/25/2013
