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Recall Observatory FDA recall evidence

Drug product

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02

D-1274-2019

April 30, 2019

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 82741
Status
Terminated
Classification
Class II
Quantity
75,825 vials
Official record key
drug-enforcement:D-1274-2019

Official wording

Reason: Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Code information: Lot #: M813513, Exp. Feb 2020

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility