Why it was recalled
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Product description
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Lot numbers, UPCs & expiration codes
Lot: G9471
Where it was sold
Nationwide and to Guatemala and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0575-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- 118 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Grato Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0575-2016, exactly as published.
Show all FDA fields
- City
- Woodbine
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 72891
- Address
- 201 Apple Blvd
- Code information
- Lot: G9471
- Postal code
- 51579-1503
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0575-2016
- Classification
- Class II
- Recalling firm
- Grato Holdings, Inc.
- Product quantity
- 118 bottles
- Termination date
- Mar 10, 2017
- Reason for recall
- Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
- Distribution pattern
- Nationwide and to Guatemala and Canada.
- Recall initiation date
- Dec 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2016