Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported April 16, 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.
Penicillin Cross Contamination
Terra-Medica Inc. recalled Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germ… — a moderate-severity action.
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germ… was recalled by Terra-Medica Inc. in April 16, 2014. Reason: Penicillin Cross Contamination. Check the official notice for the remedy. Verify recall #D-1210-2014 with the FDA Drug before acting.
The recall
Terra-Medica Inc. issued this moderate-severity FDA Drug recall — Penicillin Cross Contamination.
- Moderate
- severity level
- Class II
- classification
- April 16, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1210-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1210-2014) was formally reported on April 16, 2014, with the manufacturer initiating the action on March 3, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Terra-Medica Inc. is listed as the recalling firm, operating out of Ferndale, WA. Federal records list the affected scope as 3440 bottles.
The documented reason for this recall is: Penicillin Cross Contamination Distribution data in the federal record shows the product reached: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category — 3,146 children & baby products recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
3440 bottles
Related Recalls
6
0 from same agency
Product description
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.
Reason for recall
Penicillin Cross Contamination
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1210-2014 |
| Date reported | April 16, 2014 |
| Date initiated | March 3, 2014 |
| Recalling firm | Terra-Medica Inc. |
| Firm location | Ferndale, WA |
| Affected scope | 3440 bottles |
| Distribution | Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1210-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terra-Medica Inc.. Units affected: 3440 bottles.
Why was this product recalled? ▼
Penicillin Cross Contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2014. Severity: Moderate. Recall number: D-1210-2014.
Where was the recalled product distributed? ▼
Distribution: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1210-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported April 16, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.