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PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite

Audience: Consumer, Health Professional, Pharmacy

June 28, 2019 -- PharMEDium Services, LLC is voluntarily recalling 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to the user level. The product is being recalled because PharMEDium’s electronic customer ordering system stated it is sulfite-free, but the product contains sulfite.

Risk Statement:

Serious adverse reactions could occur in patients with a sulfite allergy who are exposed to Hydromorphone containing sulfites. The reactions may range from mild wheezing to severe bronchospasm and anaphylaxis. To date, PharMEDium Services, LLC has not received any adverse event reports related to sulfite reactions or sensitivity.

The product is used for relief of moderate to severe pain in opioid tolerant patients and is packaged as 1 mL in 3 mL BD Syringe, in packages of 5 syringes, NDC # 61553-352-78. 28,140 syringes were distributed to a total of 6 customers in the USA. The complete list of affected HYDROmorphone HCl is included in the table below which contains the product description, lot number, expiration date and NDC.

Service Code Service Code Description Lot Number Expiration Date NDC
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670030D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670031D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670032D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670033D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710015D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710016D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710017D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710018D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710019D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730028D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730029D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730030D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190740018D 06/16/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190770028D 06/17/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190770029D 06/17/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780027D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780028D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780029D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190790030D 06/19/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800012D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800013D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800015D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800016D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810033D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810034D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810035D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810036D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190840002D 06/24/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190870008D 06/27/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190910015D 07/01/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190980033D 07/08/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190990017D 07/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190990030D 07/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191000035D 07/10/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191010008D 07/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% 191010009D 07/11/2019 61553-352-78
  Sodium Chloride 1 mL in 3 mL BD Syringe      
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191010010D 07/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191050002D 07/15/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191120002D 07/22/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191160001D 07/28/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800014D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210020D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210021D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210022D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191220017D 08/01/2019 61553-352-78

The product can be identified by referring to the sample label included with this release.

PharMEDium Services, LLC has notified all six customers by email/phone and has arranged for replacement orders of all recalled products. All six customers have been advised to identify, quarantine and destroy any remaining product according to their facilities policies and procedures and to notify PharMEDium Services, LLC of the units requiring credit. Customers have been notified to 100% effectiveness and all six customers have responded with the number of syringes for credit. They have been instructed on how to receive replacement orders.

Consumers with questions regarding this recall can contact PharMEDium Services, LLC by dialing 800-523- 7749 (8:00 am – 5:00 pm Central Time) or Quality1@pharmedium.com by email. 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.

  • Complete and submit the report Online
  • Regular Mail or Fax: 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

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

Source: FDA

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