Recalls / Class II
Class IID-1206-2014
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 Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.
- Affected lot / code info
- 10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017.
Why it was recalled
Penicillin Cross Contamination.
Recalling firm
- Firm
- Terra-Medica Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1465 Slater Rd, N/A, Ferndale, Washington 98248-8919
Distribution
- Quantity
- 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons
- Distribution pattern
- Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Timeline
- Recall initiated
- 2014-03-03
- FDA classified
- 2014-04-07
- Posted by FDA
- 2014-04-16
- Terminated
- 2014-07-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1206-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.