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Recall Observatory FDA recall evidence

Drug product

NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY

D-1230-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
400 mL in Vials
Official record key
drug-enforcement:D-1230-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: a) Lot #: 160203-18, BUD: 08/01/16. b) Lot #: 160203-18, BUD: 08/01/16. c) Lot #: 160203-18, BUD: 08/01/16.

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