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Recall Observatory FDA recall evidence

Drug product

Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0

D-0055-2021

October 02, 2020

Class II

Product summary

Firm
Medichem S.A.
Event
Event 86540
Status
Terminated
Classification
Class II
Quantity
60,000 kg
Official record key
drug-enforcement:D-0055-2021

Official wording

Reason: Discoloration.

Code information: Batch: A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, A-200398

Distribution pattern: AL, NJ, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration.