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Recall Observatory FDA recall evidence

Drug product

Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

D-0374-2024

March 05, 2024

Class II

Product summary

Firm
Thea Pharma, Inc.
Event
Event 94146
Status
Terminated
Classification
Class II
Quantity
5,476 bottles
Official record key
drug-enforcement:D-0374-2024

Official wording

Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Code information: Lot #: 435019, Exp. Date 11/2024

Distribution pattern: Product was distributed nationwide within the United States

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