Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Colostat
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling mix-up - Indications on product label are incorrect.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
Affected NDC
44911-0411-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Colostat Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica NDC 44911-0411 |
FRANGULA PURSHIANA BARK 3 [hp_X]/mL; SPIGELIA ANTHELMIA WHOLE 3 [hp_X]/mL; TARAXACUM OFFICINALE 3 [hp_X]/mL; CAJUPUT OIL 6 [hp_X]/mL; GOLDENSEAL 6 [hp_X]/mL; ALUMINUM OXIDE 12 [hp_X]/mL; ARTEMISIA CINA PRE-FLOWERING TOP 12 [hp_X]/mL; CINCHONA OFFICINALIS BARK 12 [hp_X]/mL; LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL; MANDRAGORA OFFICINARUM ROOT 12 [hp_X]/mL; STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL | Liquid Oral |
Energique, Inc. | OTC |
- Recalling firm
- Grato Holdings, Inc.
- NDC code
- 44911-0411-1
- Origin
- IA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1049-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Grato Holdings, Inc.
All 2019 recalls
Class II · Moderate risk
Earache Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Ear Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Drops
Microbial contamination of non-sterile product.
Other labeling / mix-up recalls from 2019
All labeling / mix-up recalls
Class II · Moderate risk
Theraflu Cough Relief
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Class II · Moderate risk
Testosterone Topical Cream 4%
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 6 mg Capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 20 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
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