Drug product
Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
D-0578-2016
Product summary
- Event
- Event 72891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 371 bottles
- Official record key
drug-enforcement:D-0578-2016
Official wording
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Code information: Lot: G9471
Distribution pattern: Nationwide and to Guatemala and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
out of specification