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Recall Observatory FDA recall evidence

Drug product

B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1171-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
955 mL in Vials
Official record key
drug-enforcement:D-1171-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: a) Lot #: 151222-11, BUD: 05/28/16; Lot #: 151224-5, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160119-3, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160217-10, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16. b) Lot #: 151223-30, BUD: 05/28/16; Lot #: 151224-2, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160112-2, BUD: 05/28/16; Lot #: 160118-2, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160125-1, BUD: 05/28/16; Lot #: 160208-4, BUD: 05/28/16; Lot #: 160210-64, BUD: 05/28/16; Lot #: 160215-6, BUD: 05/28/16; Lot #: 160222-14, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16; Lot #: 160307-23, BUD: 06/11/16.

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