Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance - American Society of Anesthesiologists (ASA)

FDA & Washington Alerts

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

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

Product Name/
Description
Product NDC Number Type of Packaging Indication Premier Pharmacy
Labs Lot Number
Beyond Use Dates Quantity 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

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.

View this alert online here.


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