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
LAKE FOREST, Ill., July 2, 2019 /PRNewswire/ -- 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.
S
ervice Code
S
ervice 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% Sodium Chloride 1 mL in 3 mL BD Syringe
191010009D
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
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: www.fda.gov/medwatch/report.htm
-- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
View original content to download multimedia:http://www.prnewswire.com/news-releases/pharmedium-services-llc-issues-voluntary-nationwide-recall-of-0-5-mgml-hydromorphone-hcl-in-0-9-sodium-chloride-1-ml-in-3-ml-bd-syringe-due-to-presence-of-sulfite-300879587.html
SOURCE PharMEDium Services, LLC
