Terra-Medica Pleo Fort Suppositories Recall: FDA Class II

Why it was recalled

Penicillin Cross Contamination

Product description

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.

Lot numbers, UPCs & expiration codes

Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017.

Where it was sold

Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1204-2014
Classification: Class II
Status: Terminated
Recall initiated: Mar 3, 2014
FDA report date: Apr 16, 2014
Quantity: 2147 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Terra-Medica Inc.

Original FDA data

Every field from FDA enforcement report D-1204-2014, exactly as published.

Show all FDA fields

City: Ferndale
State: WA
Status: Terminated
Country: United States
Event ID: 67723
Address: 1465 Slater Rd
Code information: Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017.
Postal code: 98248-8919
Report date: Apr 16, 2014
Product type: Drugs
Recall number: D-1204-2014
Classification: Class II
Recalling firm: Terra-Medica Inc.
Product quantity: 2147 cartons
Termination date: Jul 30, 2014
Reason for recall: Penicillin Cross Contamination
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Recall initiation date: Mar 3, 2014
Initial firm notification: E-Mail
Center classification date: Apr 7, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1204-2014, published Apr 16, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Terra-Medica Pleo Fort SUPPOSITORIES 3X Recall

Summary