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Recall Observatory FDA recall evidence

Drug product

Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP

D-0227-2017

December 15, 2016

Class II

Product summary

Firm
Meta Pharmacy Services
Event
Event 76027
Status
Terminated
Classification
Class II
Quantity
150 mL
Official record key
drug-enforcement:D-0227-2017

Official wording

Reason: Lack of Sterility Assurance

Code information: Lot: 112716SB, Exp. 12/27/2016

Distribution pattern: One consignee in Las Vegas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility