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Recall Observatory FDA recall evidence

Drug product

Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.

D-1198-2014

March 03, 2014

Class II

Product summary

Firm
Terra-Medica Inc.
Event
Event 67723
Status
Terminated
Classification
Class II
Quantity
32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons
Official record key
drug-enforcement:D-1198-2014

Official wording

Reason: Penicillin Cross Contamination

Code information: (10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014.

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