FDA (Drugs) recall action 67723

Terra-Medica Inc. recalled 22 products on 2014-04-16

The FDA (Drugs) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products: 22
Announced: 2014-04-16
Critical: 0
Units: 92,852

Why these products were recalled

Penicillin Cross Contamination

Penicillin Cross Contamination.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–22 of 22

SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Suppositories Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Suppositories 3X due to penicillin cross-contamination. The affected homeopathic medicine was distributed in the US, Canada, and the Philippines.
Product
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic 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: 49807-2304-1.
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo-Fort Drops Due to Penicillin Cross-Contamination
Terra-Medica Inc. is recalling Pleo-Fort DROPS 5X homeopathic medicine due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo-Fort DROPS 5X, 10ml bottle, 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: 49807-1101-1.
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Tablets Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Tablets 5X because of penicillin cross contamination. The affected homeopathic medicine was distributed in the US, Canada, and the Philippines.
Product
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic 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: 49807-2302-1.
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Quent Homeopathic Medicine Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Quent homeopathic medicine because of penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
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…
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0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Ointment Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not Ointment because of penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic 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: 49807-2305-1.
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Fort Suppositories Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Fort Suppositories because of penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, 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: 49807-1106-1.
Category
Distribution
0 states
HighFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Ex Suppositories Due to Penicillin Cross-Contamination
Terra-Medica Inc. is recalling Pleo Ex Suppositories because of penicillin cross-contamination. The affected homeopathic antifungal products were distributed in the US, Canada, and the Philippines.
Product
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal 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: 49807-1001-1.
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Distribution
0 states
HighFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Fort Capsules Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Fort Capsules 4X due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Fort Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Fort Portable Sips homeopathic medicine because of penicillin cross-contamination. The products were distributed in the US, Canada, and the Philippines.
Product
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. 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: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic…
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Stolo Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Stolo DROPS 6X homeopathic medicine due to penicillin cross-contamination. Consumers should stop using the product and contact the company for a refund.
Product
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Quent Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Quent DROPS 5X oral homeopathic medicine due to penicillin cross contamination.
Product
Pleo Quent DROPS 5X, 10 mL Bottles, 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: 49807-2901-1.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Quent Capsules Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Quent capsules due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Quent CAPSULES 4X, 20 Capsule 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: 49807-2902-1.
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Ex Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Ex DROPS 5X homeopathic antifungal medicine due to penicillin cross-contamination. The product was distributed in the US, Canada, the Philippines, and online.
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not DROPS Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not DROPS homeopathic medicine due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic 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: 49807-2301-1.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Not Portable Sips oral homeopathic medicine due to penicillin cross-contamination. The products were distributed in the US, Canada, and the Philippines.
Product
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic 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: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL…
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Ex Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Ex Portable Sips homeopathic medicine due to penicillin cross-contamination.
Product
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral…
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Distribution
0 states
HighFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine due to penicillin cross-contamination.
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…
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Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Fort Tablets Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Fort Tablets 5X due to penicillin cross-contamination. The product was distributed nationwide and internationally.
Product
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid 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: 49807-1102-1.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Quent Suppositories Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Quent Suppositories 3X due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Quent SUPPOSITORIES 3X, 10 Suppository 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: 49807-2904-1.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Nota-Quent Drops Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Nota-Quent Drops because of penicillin cross-contamination. The product is distributed in the US, Canada, and the Philippines.
Product
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.
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Distribution
0 states
HighFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Capsules Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Capsules 4X because of penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2014-04-16
Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine because of penicillin cross-contamination.
Product
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic 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: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL…
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0 states