The FDA has issued another urgent recall due to an over-the-counter supplement containing undeclared drugs. This recall is especially concerning because 123Herbal marketed their supplement as a treatment for itching associated with pregnancy, as well as medical conditions such as eczema. All consumers, particularly those who are pregnant, must be diligent in verifying the safety of their medications and supplements. The drugs contained in this supplement can cause serious health outcomes for those who ingest it.
As of the date this notice was written, the manufacturer, 123Herbals, has not reported any known adverse events related to this recall.
SUMMARY
Date of Recall:
Announced: September 18, 2024
Public Notification: September 20, 2024
Name(s) of Drug:
Vail-Bon Jie Yang Wan
Company Name:
123Herbals
Drug Indication:
Itching
Product Description
Vail-Bon Jie Yang Wan capsules were distributed through the 123Herbals website and were marketed for the treatment of itching due to skin diseases and pregnancy. They were packaged in bottles that were distributed in boxes bearing a flower pattern and gold-embossed Chinese lettering. Each box contains 30 capsules.
Reason for Recall
The FDA has not approved 123Herbals to sell drugs, yet their supplement contains undeclared drugs. Testing of the capsules revealed the presence of both Dexamethasone and Chlorpheniramine. The use of these drugs without proper medical oversight is extremely dangerous, especially for pregnant women.
Impacts
Consumers who ingest the supplement are inadvertently consuming dexamethasone and chlorpheniramine as well. Without proper medical oversight and careful dosing, these drugs can lead to life-threatening medical outcomes. Furthermore, consumers who are prescribed these medications and take them in conjunction with Vail-Bon Jie Yang Wan capsules are receiving higher-than-prescribed doses of the drugs.
Dexamethasone can cause serious side effects, including:
- Abnormal fat deposits on the face and neck
- Aggression
- Pounding in the ears
- Mood changes such as depression, anxiety, and mania
- Weight gain
- Upset stomach
- Diarrhea
- Facial hair growth in females
- Loss of sexual desires or abilities
- Inability to sleep
- Dry skin
- Acne
- Thinning hair
- Blurred vision
Chlorpheniramine can cause serious side effects, including:
- Overexcitement
- Loss of coordination
- Drowsiness
- Vision changes
- Difficulty urinating
- Headache
- Vomiting
- Loss of consciousness
- Seizures
Recall Product Information
Consumers who have ingested Vail-Bon Jie Yang Wan capsules should immediately stop using the product and read below for further instructions on seeking medical attention and properly disposing of the tainted supplements.
Have you found that you are in possession of the supplement named in the recall? Here’s what you should do:
Consumers
- Stop using the supplement right away.
- Notify your doctor that you have used the medication.
- Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
- If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact 123Herbals with questions at (626) 656-3202. They are available Monday through Friday from 8:00 a.m. to 5:00 p.m. PT. They are also available via email at 123Herbals@gmail.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock included in the recall.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact 123Herbals with questions at (626) 656-3202. They are available Monday through Friday from 8:00 a.m. to 5:00 p.m. PT. They are also available via email at 123Herbals@gmail.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and consider removing stock included in the warning.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact 123Herbals with questions at (626) 656-3202. They are available Monday through Friday from 8:00 a.m. to 5:00 p.m. PT. They are also available via email at 123Herbals@gmail.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
