Recalls / Class II
Class IID-1195-2014
Product
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.
- Affected lot / code info
- Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 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
- 21,445 Bottles
- 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-1195-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.