{"id":51218,"date":"2026-08-04T22:44:00","date_gmt":"2026-08-04T20:44:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=5cafb3873eff3a3823d38873ccfcf69d"},"modified":"2026-08-04T22:44:00","modified_gmt":"2026-08-04T20:44:00","slug":"fresenius-kabi-issues-voluntary-nationwide-recall-of-one-lot-of-morphine-sulfate-injection-usp-in-a-simplist-prefilled-syringe-due-to-labeling-mix-up","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=51218","title":{"rendered":"Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist\u00ae Prefilled Syringe Due to Labeling Mix-up"},"content":{"rendered":"

LAKE ZURICH, Ill.--(BUSINESS WIRE)--#CommittedToLife<\/a>--Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist\u00ae<\/sup> 2 mg\/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg\/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg\/0.5 mL. This recall is being conducted to the user level.<\/p><\/a><\/a><\/a><\/a>

\nUse of a MicroVault labeled as Morphine Sulfate Injection 2 mg\/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg\/0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants. To date, no adverse event reports have been received for this lot number.<\/p>

\nMorphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.<\/p>\n\n\n

\nProduct Name\/Product size<\/span><\/b><\/p><\/td>

\nUnit of Use NDC Number<\/span><\/b><\/p><\/td>

\nUnit of Sale NDC Number<\/span><\/b><\/p><\/td>

\nProduct<\/span><\/b><\/p>

\nCode<\/span><\/b><\/p><\/td>

\nLot Number<\/span><\/b><\/p><\/td>

\nExpiration<\/span><\/b><\/p>

\nDate<\/span><\/b><\/p><\/td>

\nFirst Ship<\/span><\/b><\/p>

\nDate<\/span><\/b><\/p><\/td>

\nLast Ship<\/span><\/b><\/p>

\nDate<\/span><\/b><\/p><\/td><\/tr>\n

\nMorphine Sulfate Injection USP, Simplist\u00ae<\/sup> 2 mg \/ 1 mL, 1 mL fill in a single dose 1 mL Simplist\u00ae<\/sup> prefilled syringe<\/b><\/p><\/td>

\n76045-004-01<\/b><\/p><\/td>

\n76045-004-11<\/b><\/p><\/td>

\n764411<\/b><\/p><\/td>

\n6402820<\/b><\/p><\/td>

\n12\/2028<\/b><\/p><\/td>

\n01\/29\/<\/b><\/p>

\n2026<\/b><\/p><\/td>

\n06\/09\/<\/b><\/p>

\n2026<\/b><\/p><\/td><\/tr>\n<\/table>

\nProduct was distributed nationwide to distributors and wholesalers.<\/p>

\nFresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.<\/p>

\nIf health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.<\/p>

\nConsumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.<\/p>

\nAdverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com<\/a> or adverse.events.USA@fresenius-kabi.com<\/a>.<\/p>

\nAdverse 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.<\/p>