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Recall Observatory FDA recall evidence

Drug product

LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY

D-1202-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
1000 mL in Vials
Official record key
drug-enforcement:D-1202-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 160203-2, BUD: 07/31/16

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