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Recall Observatory FDA recall evidence

Drug product

Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.

D-1210-2014

March 03, 2014

Class II

Product summary

Firm
Terra-Medica Inc.
Event
Event 67723
Status
Terminated
Classification
Class II
Quantity
3440 bottles
Official record key
drug-enforcement:D-1210-2014

Official wording

Reason: Penicillin Cross Contamination

Code information: Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108.

Distribution pattern: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Penicillin Cross Contamination