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Recall Observatory FDA recall evidence

Drug product

Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771

D-0457-2017

January 18, 2017

Class II

Product summary

Firm
VistaPharm, Inc.
Event
Event 75650
Status
Terminated
Classification
Class II
Quantity
67,955 bottles
Official record key
drug-enforcement:D-0457-2017

Official wording

Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Code information: a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contaminated with Burkholderia cepacia