Recalls / Class II
Class IID-1211-2014
Product
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. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.
- Affected lot / code info
- 10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 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
- 111 10 x 1 mls; 39 50 x 1 mls
- 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-1211-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.