Multi-event December 2015 FDA Recall Drug by Grato Holdings, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Grato Holdings, Inc. on December 22, 2015 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile products; testing revealed out of specification results for total aerobic microbiological count. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0577-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
224 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Batch or Lot Expiration Information
Lot# Lot: G9471
Recall Number: D-0575-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
118 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot: G9471
Recall Number: D-0576-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
201 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Batch or Lot Expiration Information
Lot# Lot: G9471
Recall Number: D-0579-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
90 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Batch or Lot Expiration Information
Lot# Lot: G9471
Recall Number: D-0578-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
371 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: G9471
Recall Number: D-0580-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
12-22-2015
01-27-2016
118 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Grato Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and to Guatemala and Canada.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: G9471
