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Recall Observatory FDA recall evidence

Drug product

SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417

D-0104-2020

September 12, 2019

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 83789
Status
Terminated
Classification
Class II
Quantity
1350 syringes
Official record key
drug-enforcement:D-0104-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility