Recalls / Class II
Class IID-0580-2016
Product
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
- Affected lot / code info
- Lot: G9471
Why it was recalled
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recalling firm
- Firm
- Grato Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Apple Blvd, N/A, Woodbine, Iowa 51579-1503
Distribution
- Quantity
- 118 bottles
- Distribution pattern
- Nationwide and to Guatemala and Canada.
Timeline
- Recall initiated
- 2015-12-22
- FDA classified
- 2016-01-20
- Posted by FDA
- 2016-01-27
- Terminated
- 2017-03-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0580-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.