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Recall Observatory FDA recall evidence

Drug product

SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1238-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
884 mL in Vials
Official record key
drug-enforcement:D-1238-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 151130-35, BUD: 05/21/16; Lot #: 151202-28, BUD: 05/21/16; Lot #: 151223-68, BUD: 05/21/16; Lot #: 151216-20, BUD: 05/21/16; Lot #: 151123-77, BUD: 05/21/16; Lot #: 151204-22, BUD: 05/21/16; Lot #: 160111-30, BUD: 05/21/16; Lot #: 160112-27, BUD: 05/21/16; Lot #: 160120-8, BUD: 05/21/16; Lot #: 160118-12, BUD: 05/21/16; Lot #: 160119-20, BUD: 05/21/16; Lot #: 160202-37, BUD: 05/21/16; Lot #: 160208-61, BUD: 05/21/16; Lot #: 160208-62, BUD: 05/21/16; Lot #: 160216-37, BUD: 08/14/16; Lot #: 160216-38, BUD: 08/14/16; Lot #: 160216-35, BUD: 08/14/16; Lot #: 160216-40, BUD: 08/14/16; Lot #: 160223-27, BUD: 08/14/16; Lot #: 160229-43, BUD: 08/14/16; Lot #: 160303-22, BUD: 08/14/16; Lot #: 160309-17, BUD: 08/14/16

Distribution pattern: U.S. Nationwide, Japan, and New Zealand.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility