Why it was recalled
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Product description
Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Lot numbers, UPCs & expiration codes
Lot #: 101471, Exp 08/01/2020
Where it was sold
Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
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-0504-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 1 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Washington Homeopathic Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0504-2020, exactly as published.
Show all FDA fields
- City
- Berkeley Springs
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 84213
- Address
- 260 J R Hawvermale Way
- Code information
- Lot #: 101471, Exp 08/01/2020
- Postal code
- 25411-6957
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0504-2020
- Classification
- Class II
- Recalling firm
- Washington Homeopathic Products, Inc.
- Product quantity
- 1 bottle
- Termination date
- Jan 4, 2023
- Reason for recall
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
- Distribution pattern
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
- Recall initiation date
- Nov 8, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2019