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Recall Observatory FDA recall evidence

Drug product

NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.

D-0702-2018

April 11, 2018

Class II

Product summary

Firm
Premier Pharmacy Labs Inc
Event
Event 79803
Status
Terminated
Classification
Class II
Quantity
600 syringes
Official record key
drug-enforcement:D-0702-2018

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: Lot: NEO022218SVDS BUD: 8/21/2018

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