June 18, 2019

 

Problem

Description

Premier Pharmacy Labs is issuing a voluntary product recall for all sterile products, within expiration date, due to a lack of sterility assurance. Concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination, and lack of product specific process validations.  The potentially affected lots were distributed between 09Jan2019 and 02May2019.

 

Hazard

Involved

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

 

Affected Product

 

PRODUCT LOT Beyond Use Date
Atropine Sulfate 0.8mg/2mL (0.4mg/mL) PF INJ 2mL syringe ATR022219NREC 06/22/2019
Brilliant Blue 0.5mg/mL (0.05%)  Ophth PF INJ 1mL vial BRI022119NREC 08/20/2019
Buprenorphine HCL Preserved INJ 12mg/20mL (0.6mg/mL) 20mL vial BUP030819NRVA 08/31/2019
Chlorpromazine HCL 25mg/mL INJ 1mL vial

 

 

CHL013019IJVA 07/29/2019
CHL013119KMSVA 07/30/2019
CHL021919NREC 08/18/2019
Dexamethasone Sodium Phosphate 24mg/mL PF INJ 1mL syringe DEX020119NRVA 07/01/2019
Droperidol 0.625mg/mL 1mL INJ 1mL syringe

 

 

 

 

 

DRO012119NRVA 07/20/2019
DRO013019IJVA 07/29/2019
DRO021919KMSEC 08/18/2019
DRO030819NRVA 09/04/2019
DRO032119KMSEC 09/17/2019
DRO032119KMSEC1 09/17/2019
Isoproterenol Sterile-Sterile 200mcg/50mL INJ Bag

 

 

 

ISO122618SVVA 06/24/2019
ISO010819SVVA 07/07/2019
ISO011619SVVA 07/15/2019
ISO011619SVVA1 07/15/2019
Isoproterenol Non-Sterile to Sterile 500mcg/50mL INJ Bag ISO022219SVEC1 08/21/2019
Isoproterenol Non-Sterile to Sterile 200mcg/50mL INJ Bag

 

 

 

 

 

 

 

 

 

ISO011119SVVA 07/10/2019
ISO011119SVVA1 07/10/2019
ISO020719SVVA 08/06/2019
ISO020719SVVA1 08/06/2019
ISO022219SVEC 08/21/2019
ISO022719SVEC 08/26/2019
ISO022719SVEC1 08/26/2019
ISO032519SVEC 09/21/2019
ISO032519SVEC1 09/21/2019
ISO032619SVEC1 09/22/2019
Lidocaine/Phenylephrine 0.5%/0.75% HCL PF INJ 1mL vial LPH040319KMSEC 09/30/2019
Mitomycin 40mg/10mL (4mg/mL) 10mL PF Irrigation

 

 

 

 

 

 

MIT013019NWVA 07/29/2019
MIT020519IJVA 08/04/2019
MIT020819SVVA 08/07/2019
MIT022119SVVA 08/20/2019
MIT022619IJEC 08/25/2019
MIT032119SVEC 09/17/2019
MIT040319SVEC 09/30/2019
Naloxone HCL Preserved INJ 500mg/50mL (10mg/mL) 50mL Vial NAL030419MMEC 07/02/2019
Neostigmine Methylsulfate 5mg/5mL (1mg/mL) 5mL syringe

 

 

 

 

 

 

NEO013019NRVA 07/29/2019
NEO021219NRAB 08/11/2019
NEO022619NREC 08/25/2019
NEO030719NREC 09/03/2019
NEO032119NREC 09/17/2019
NEO032119NREC1 09/17/2019
NEO032819NREC1 09/24/2019
Orphenadrine Citrate 30mg/mL 1mL Syringe *Contains Sulfites*

 

 

 

 

 

 

 

(Continued)

 

Orphenadrine Citrate 30mg/mL 1mL Syringe *Contains Sulfites*

ORP012919NRVAA 07/28/2019
ORP012919NRVAB 07/28/2019
ORP021919NRECA 08/18/2019
ORP021919NRECB 08/18/2019
ORP022519NRECA 08/24/2019
ORP022519NRECB 08/24/2019
ORP031119KMSECA 09/07/2019
ORP031119KMSECB 09/07/2019
ORP031119KMSEC1A 09/07/2019
ORP031119KMSEC1B 09/07/2019
Phenylephrine HCL in Sodium Chloride PF 1000mcg/10mL (100mcg/mL) 10mL syringe

 

 

PHE022019NREC 06/20/2019
PHE022719NREC 06/27/2019
PHE030819KMSVA1 07/06/2019
Riboflavin 5 Phosphate Sodium 6.35mg/mL Ophth Solution 3mL dropper RIB012119NRVAR 06/30/2019
Succinylcholine Chloride INJ 100mg/5mL (20mg/mL) 5mL syringe

 

 

 

 

 

 

 

 

 

SUC012119NWVA 06/20/2019
SUC012919IJVA 06/28/2019
SUC020419NWVA 07/04/2019
SUC032619IJEC 08/23/2019
SUC032919SVEC 08/26/2019
SUC030719SVEC 08/04/2019
SUC030819SVVA 08/05/2019
SUC031119SVEC 08/08/2019
SUC032819IJEC 08/25/2019
SUC032819IJEC1 08/25/2019
Succinylcholine Chloride INJ 200mg/10mL (20mg/mL) 10mL syringe

 

 

 

 

 

SUC012119NWVA1 06/20/2019
SUC022819SVEC 07/28/2019
SUC030519SVEC 08/02/2019
SUC030619SVEC 08/03/2019
SUC032519NWEC 08/22/2019
SUC032719SVEC 08/24/2019
Sodium Bicarbonate INJ 8.4% 50mEq/50mL (84mg/mL) (1mEq/mL) 50mL Vial

 

 

 

 

 

 

 

 

 

 

 

 

(Continued)

 

Sodium Bicarbonate INJ 8.4% 50mEq/50mL (84mg/mL) (1mEq/mL) 50mL Vial

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SOD122618NWVA 06/24/2019
SOD122018MMVA 06/18/2019
SOD010419MMVA 07/03/2019
SOD010719IJVA 07/06/2019
SOD010719IJVA1 07/06/2019
SOD010719KMSVA 07/06/2019
SOD010919MMVA 07/08/2019
SOD011019KMSVA 07/09/2019
SOD011419KMSVA 07/13/2019
SOD011419KMSVA1 07/13/2019
SOD011519IJVA 07/14/2019
SOD011519IJVA1 07/14/2019
SOD011619KMSVA 07/15/2019
SOD011619KMSVA1 07/15/2019
SOD012219IJSVVA 07/21/2019
SOD020119KMSVA 07/31/2019
SOD020519NWVA 08/04/2019
SOD020519NWVA1 08/04/2019
SOD020819KMSVA 08/07/2019
SOD020819KMSVA1 08/07/2019
SOD021119IJVA 08/10/2019
SOD021119IJVA1 08/10/2019
SOD021319IJVAR 08/12/2019
SOD021319IJVA1 08/12/2019
SOD021219KMSAB 08/11/2019
SOD021919SVEC 08/18/2019
SOD021919SVVA 08/18/2019
SOD022019KMSEC 08/19/2019
SOD022019KMSEC1 08/19/2019
SOD022119IJEC 08/20/2019
SOD022119IJEC1 08/20/2019
SOD030119SVEC 08/28/2019
SOD030619IJEC1 09/02/2019
SOD030719KMSEC 09/03/2019
SOD030719KMSEC1 09/03/2019
SOD030819NWVA 09/04/2019
SOD030819NWVA1 09/04/2019
SOD031119IJEC 09/07/2019
SOD031119IJEC1 09/07/2019
SOD032819SVEC 09/24/2019
SOD032819SVEC1 09/24/2019
 

 

 

 
Actions to be Taken
  1. Locate and remove all affected product lots from your facility, and destroy per the hospital/institution protocol.  The product, description, and beyond use date (BUD) can be found on the individual product or shipping bag.

 

  1. Contact Premier Pharmacy Labs for Service for any additional questions and outstanding credits.  Premier Pharmacy Labs can be reached at 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday.

 

  1. Complete the enclosed Premier Pharmacy Labs customer reply form and return it to Premier Pharmacy Labs by faxing it to 1-800-868-4978 or scanning and e-mailing it to recalls@premierpharmacylabs.com. Returning the Premier Pharmacy Labs customer reply form will prevent you from receiving repeat notices.

 

  1. If you distribute to other facilities or departments within your institution (e.g. Pharmacy, ER, ICU, NICU, PICU) please forward a copy of this communication to them.

 

 

 

Further Information and Support For general questions regarding this communication, contact Premier Pharmacy Labs at 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday.

 

 

The United States Food and Drug Administration (FDA) has been notified of this action.  Any adverse reaction or quality problems experience with the use of these, or any other Premier Pharmacy Labs products, may be reported using the following options:

 

  • Calling Premier Pharmacy Labs at 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time.
  • Emailing to Premier Pharmacy Labs at: recalls@premierpharmacylabs.com.
  • Reporting to the FDA Medwatch Adverse Event Reporting Program at www.fda.gov/medwatch and 1-800-FDA-1088.

 

 

We apologize for any inconvenience this may cause you and your staff.