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Recall Observatory FDA recall evidence

Drug product

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

D-66462-001

October 02, 2013

Class II

Product summary

Firm
Nephron Pharmaceuticals Corp.
Event
Event 66462
Status
Terminated
Classification
Class II
Quantity
689,568 cartons
Official record key
drug-enforcement:D-66462-001

Official wording

Reason: Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Code information: Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility