Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance

Source: FDA Drug Recalls
Wed Apr 11, 2018 3:45PM

Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance:

Product Name/DescriptionProduct NDC NumberType of PackagingIndicationPremier Pharmacy Labs Lot NumberBeyond Use DatesQuantity ShippedDate(s) Distributed
Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free Injection69623-129-10Rigid plastic syringe, 3mLpain reliever/
reducer
MOR030518IJDSAMOR030518IJDSB MOR030518IJDSC MOR030518IJDSD

MOR030518IJDSE

06/03/201806/03/201806/03/201806/03/2018

06/03/2018

925904928930

868

03/23/201803/23/201803/23/201803/23/2018

03/28/2018

Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection69623-127-10Rigid plastic syringe, 3mLpain reliever/
reducer
MOR022318NWDSA MOR022318NWDSB MOR022318NWDSC MOR022318NWDSD

MOR022318NWDSE

05/24/201805/24/201805/24/201805/24/2018

05/24/2018

540925920902

905

03/06/201803/06/201803/06/201803/16/2018

03/16/2018

Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection69623-249-10Rigid plastic syringe, 3mLpain reliever/
reducer
HYD030118IJDSA HYD030118IJDSB HYD030118IJDSD

HYD030118IJDSE

05/30/201805/30/201805/30/2018

05/30/2018

921870928

851

03/22/201803/22/201803/22/2018

03/22/2018

Neostigmine Methylsulfate (Single Dose Syringe) 1mg/mL Injection69623-234-14Rigid plastic syringe, 3mLto reverse some of the nerve and muscle blocking agents used in surgery.NEO022218SVDS08/21/201860003/19/2018

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. To date, Premier Pharmacy Labs has not received any reports of adverse events related to this issue, but understanding the potential risk, is voluntarily initiating this product recall.

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.

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.

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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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