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Recall Observatory FDA recall evidence

Drug product

Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.

D-1203-2014

March 03, 2014

Class II

Product summary

Firm
Terra-Medica Inc.
Event
Event 67723
Status
Terminated
Classification
Class II
Quantity
211 10 x 1 ml vials; 152 50 x 1 vials
Official record key
drug-enforcement:D-1203-2014

Official wording

Reason: Penicillin Cross Contamination

Code information: 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015.

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