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Recall Observatory FDA recall evidence

Drug product

DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1181-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
2218 mL in Vials
Official record key
drug-enforcement:D-1181-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: a) Lot #: 151217-2, BUD: 05/30/16; Lot #: 160115-6, BUD: 05/30/16; Lot #: 160303-8, BUD: 08/30/16; Lot #: 160303-10, BUD: 08/30/16. b) Lot #: 151203-37, BUD: 05/30/16; Lot #: 151203-72, BUD: 05/30/16; Lot #: 151209-7, BUD: 05/30/16; Lot #: 151209-8, BUD: 05/30/16; Lot #: 151209-9, BUD: 05/30/16; Lot #: 151209-10, BUD: 05/30/16; Lot #: 151209-11, BUD: 05/30/16; Lot #: 151209-13, BUD: 05/30/16; Lot #: 151209-14, BUD: 05/30/16; Lot #: 160104-31, BUD: 05/30/16; Lot #: 160113-77, BUD: 05/30/16; Lot #: 151218-7, BUD: 06/15/16; Lot #: 151218-8, BUD: 06/15/16; Lot #: 160113-78, BUD: 07/11/16; Lot #: 160113-4, BUD: 07/11/16; Lot #: 160122-10, BUD: 07/20/16; Lot #: 160201-6, BUD: 07/30/16; Lot #: 160201-7, BUD: 07/30/16; Lot #: 160204-9, BUD: 08/02/16; Lot #: 160208-5, BUD: 08/06/16; Lot #: 160208-6, BUD: 08/06/16; Lot #: 160210-65, BUD: 08/08/16; Lot #: 160210-66, BUD: 08/08/16; Lot #: 160210-67, BUD: 08/08/16; Lot #: 160210-68, BUD: 08/08/16; Lot #: 160210-69, BUD: 08/08/16; Lot #: 160303-12, BUD: 08/30/16; Lot #: 160303-13, BUD: 08/30/16; Lot #: 160309-2, BUD: 09/05/16.

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