Drug recall: Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA…
Class II FDA enforcement event 67723. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Penicillin Cross Contamination
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Terra-Medica Inc. started this drug recall on 3 Mar 2014. The firm address in the FDA record is in Ferndale, WA. FDA put the recall in Class II. FDA event 67723 has 22 product records. The first FDA enforcement report date is 16 Apr 2014. The record gives the status Terminated, with the termination date 30 Jul 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Recalling firm
Terra-Medica Inc., Ferndale, WA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1191-2014 | 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. | 1368 tubes | Class II | Terminated | 16 Apr 2014 |
| D-1192-2014 | 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. | 4860 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1193-2014 | 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. | 7408 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1194-2014 | 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. | 4955 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1195-2014 | 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. | 21,445 Bottles | Class II | Terminated | 16 Apr 2014 |
| D-1196-2014 | 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 Cartons, Oral Homeopathic Medicine, OTC… | 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons | Class II | Terminated | 16 Apr 2014 |
| D-1197-2014 | 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 Cartons, Oral Homeopathic Medicine, OTC… | 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons | Class II | Terminated | 16 Apr 2014 |
| D-1198-2014 | 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.… | 32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons | Class II | Terminated | 16 Apr 2014 |
| D-1199-2014 | 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. | 6120 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1200-2014 | 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. | 3725 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1201-2014 | 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. | 3066 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1202-2014 | 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. | 10,725 bottles | Class II | Terminated | 16 Apr 2014 |
| D-1203-2014 | 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:… | 211 10 x 1 ml vials; 152 50 x 1 vials | Class II | Terminated | 16 Apr 2014 |
| D-1204-2014 | 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. | 2147 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1205-2014 | 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. | 4050 cartons | Class II | Terminated | 16 Apr 2014 |
| D-1206-2014 | 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 Medicine, OTC Only. Made in Germany for: SANUM… | 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons | Class II | Terminated | 16 Apr 2014 |
| D-1207-2014 | 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. | 8405 bottles | Class II | Terminated | 16 Apr 2014 |
| D-1208-2014 | 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. | 4770 Cartons | Class II | Terminated | 16 Apr 2014 |
| D-1209-2014 | 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. | 5940 Packages | Class II | Terminated | 16 Apr 2014 |
| D-1210-2014 | 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. | 3440 bottles | Class II | Terminated | 16 Apr 2014 |
| D-1211-2014 | 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 Homeopathic Medicine, OTC Only. Made in Germany.… | 111 10 x 1 mls; 39 50 x 1 mls | Class II | Terminated | 16 Apr 2014 |
| D-1212-2014 | 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. | 428 bottles | Class II | Terminated | 16 Apr 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class II
- 58%
- Product records in this event
- 22
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1191-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 67723. https://recallregister.com/fda/ii/67723/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
- What quantity of product is in FDA event 67723?
- The event has 22 product records. The first record gives this quantity:
1368 tubes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 58% of the 313 drug events that started in 2014 are in Class II.