V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, In...
FDA Drug Recall #D-0099-2024 - Class III, October 30, 2023
Recall Summary
| Recall Number | D-0099-2024 |
| Classification | Class III, Low risk |
| Date Initiated | October 30, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Grato Holdings, Inc. |
| Location | Woodbine, IA |
| Product Type | Drugs |
| Quantity | 1,333 30mL bottles |
Product Description
V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
Reason for Recall
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Distribution Pattern
Distributed to one direct account in Florida with possible further distribution out of state.
Lot / Code Information
Lot: Z65842 no exp date on product
Other Recalls from Grato Holdings, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0989-2022 | Class II | Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) b... | May 24, 2022 |
| D-0990-2022 | Class II | Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 m... | May 24, 2022 |
| D-0991-2022 | Class II | Earache Drops, 0.33 FL OZ (10 mL) bottles, Dist... | May 24, 2022 |
| D-0653-2021 | Class III | B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, D... | Jun 18, 2021 |
| D-0099-2021 | Class III | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Di... | Sep 17, 2020 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.