Why it was recalled
Penicillin Cross Contamination
Product description
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.
Lot numbers, UPCs & expiration codes
Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018.
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-1209-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 3, 2014
- FDA report date
- Apr 16, 2014
- Quantity
- 5940 Packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Terra-Medica Inc.
Original FDA data
Every field from FDA enforcement report D-1209-2014, 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 # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018.
- Postal code
- 98248-8919
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1209-2014
- Classification
- Class II
- Recalling firm
- Terra-Medica Inc.
- Product quantity
- 5940 Packages
- Termination date
- Jul 30, 2014
- Reason for recall
- Penicillin Cross Contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
- Recall initiation date
- Mar 3, 2014
- Initial firm notification
- Center classification date
- Apr 7, 2014