News & Press: Patient Safety

Recall Alert: Sterile Injectable Products by Premier Pharmacy Labs

Friday, April 13, 2018  
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SIS Patient Safety Alert 04/13/2018: Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome.

BACKGROUND: The product can be identified by the product description in the above table and beyond use date (BUD) on the individual product or shipping bag. The listed product lots were distributed Nationwide to hospital pharmacy, clinic, and healthcare facilities.

RECOMMENDATION: Premier Pharmacy Labs is notifying its distributors and customers by certified letter and is arranging for return/replacement of all recalled products. Hospital pharmacy, clinic, and healthcare facilities that have product which is being recalled should stop using and return to Premier Pharmacy Labs per the official recall notification/customer reply form included in the certified letter sent to all affected clients.

Product Name/
Description

Product
NDC Number

Type of Packaging

Indication

Premier Pharmacy Labs Lot Number

Beyond Use Dates

#
Shipped

Date(s) Distributed

Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free Injection

69623-129-10

Rigid plastic syringe, 3mL

pain reliever/
reducer

MOR030518IJDSA
MOR030518IJDSB
MOR030518IJDSC
MOR030518IJDSD
MOR030518IJDSE

06/03/2018
06/03/2018
06/03/2018
06/03/2018
06/03/2018

925
904
928
930
868

03/23/2018
03/23/2018
03/23/2018
03/23/2018
03/28/2018

Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection

69623-127-10

Rigid plastic syringe, 3mL

pain reliever/
reducer

MOR022318NWDSA
MOR022318NWDSB
MOR022318NWDSC
MOR022318NWDSD
MOR022318NWDSE

05/24/2018
05/24/2018
05/24/2018
05/24/2018
05/24/2018

540
925
920
902
905

03/06/2018
03/06/2018
03/06/2018
03/16/2018
03/16/2018

Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection

69623-249-10

Rigid plastic syringe, 3mL

pain reliever/
reducer

HYD030118IJDSA
HYD030118IJDSB
HYD030118IJDSD
HYD030118IJDSE

05/30/2018
05/30/2018
05/30/2018
05/30/2018

921
870
928
851

03/22/2018
03/22/2018
03/22/2018
03/22/2018

Neostigmine Methylsulfate (Single Dose Syringe) 1mg/mL Injection

69623-234-14

Rigid plastic syringe, 3mL

to reverse some of the nerve and muscle blocking agents used in surgery.

NEO022218SVDS

08/21/2018

600

03/19/2018

 

Consumers with questions regarding this recall can contact Premier Pharmacy Labs by calling 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday or sending an email to recalls@premierpharmacylabs.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the FDA MedWatch Safety Alert for further details.

Source: Food and Drug Administration - Accessed 04/13/2018


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