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Recall Observatory FDA recall evidence

Drug product

Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.

D-1205-2014

March 03, 2014

Class II

Product summary

Firm
Terra-Medica Inc.
Event
Event 67723
Status
Terminated
Classification
Class II
Quantity
4050 cartons
Official record key
drug-enforcement:D-1205-2014

Official wording

Reason: Penicillin Cross Contamination

Code information: Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017.

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