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Recall Observatory FDA recall evidence

Drug product

Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35

D-0791-2016

February 12, 2016

Class II

Product summary

Firm
Walter's Pharmacy
Event
Event 73336
Status
Terminated
Classification
Class II
Quantity
2 bottles
Official record key
drug-enforcement:D-0791-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 020316 and 011216

Distribution pattern: PA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility