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Recall Observatory FDA recall evidence

Drug product

Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

D-0045-2016

September 22, 2015

Class II

Product summary

Firm
Bedford Pharmacy
Event
Event 72233
Status
Terminated
Classification
Class II
Quantity
2 bottles
Official record key
drug-enforcement:D-0045-2016

Official wording

Reason: Lack of assurance of sterility

Code information: Lot #: 07232015@1, Exp 09/06/29015

Distribution pattern: NH, MA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility