FDA Recall D-1488-2019

PharMEDium Services, LLC · Dayton, NJ

Class I — life-threatening Terminated 361 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

Lot / code: Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.

Quantity: 28,140 syringes

Reason for recall

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

Recall record

Recall number: D-1488-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2019-06-07
Classified by FDA Center: 2019-07-16
FDA published: 2019-07-10
Terminated: 2020-06-02
Recalling firm: PharMEDium Services, LLC
Firm location: Dayton, NJ

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