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Recall Observatory FDA recall evidence

Drug product

Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10

D-0699-2018

April 11, 2018

Class II

Product summary

Firm
Premier Pharmacy Labs Inc
Event
Event 79803
Status
Terminated
Classification
Class II
Quantity
4555 syringes
Official record key
drug-enforcement:D-0699-2018

Official wording

Reason: 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.

Code information: Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility