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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67080
Product Type Drugs
Status Ongoing
Recalling Firm Zions RX Formulations Services LLC dba RX Formuations Serv.
City Mesa
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-12
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern AZ

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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 Class II 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. 38 units D-1219-2014
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013 Class II 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. 60 units D-1218-2014
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 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 Class II 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. 610 units D-1217-2014
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 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 Class II 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. 1,495 Bags D-1216-2014
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 Lot #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013 Class II 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. 95 Vials D-1215-2014
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 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 Class II 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. 861 Bags D-1214-2014
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. Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013 Class I 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. 450 Vials D-1213-2014
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