Product: Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe.  8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Reason for recall: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Recall initiated: 20180411
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated