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Recall Observatory FDA recall evidence

Drug product

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

D-1883-2019

September 20, 2019

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 83843
Status
Terminated
Classification
Class II
Quantity
60,176 bottles
Official record key
drug-enforcement:D-1883-2019

Official wording

Reason: Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

Code information: Lot #: 031908A, Exp 03/20

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility