Recalls / Class II
Class IID-1202-2014
Product
Pleo Quent DROPS 5X, 10 mL Bottles, 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: 49807-2901-1.
- Affected lot / code info
- Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016.
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
- 10,725 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-1202-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.