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Recall Observatory FDA recall evidence

Drug product

Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.

D-1193-2014

March 03, 2014

Class II

Product summary

Firm
Terra-Medica Inc.
Event
Event 67723
Status
Terminated
Classification
Class II
Quantity
7408 cartons
Official record key
drug-enforcement:D-1193-2014

Official wording

Reason: Penicillin Cross Contamination

Code information: Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 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