Why it was recalled
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Product description
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Lot numbers, UPCs & expiration codes
All lots.
Where it was sold
Nationwide in the USA
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-1595-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 1, 2020
- FDA report date
- Sep 30, 2020
- Quantity
- 21,511 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Protein Shoppe
Original FDA data
Every field from FDA enforcement report D-1595-2020, exactly as published.
Show all FDA fields
- City
- Pharr
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86377
- Address
- 101 E Interstate 2
- Code information
- All lots.
- Postal code
- 78577-6561
- Report date
- Sep 30, 2020
- Product type
- Drugs
- Recall number
- D-1595-2020
- Classification
- Class I
- Recalling firm
- The Protein Shoppe
- Product quantity
- 21,511 tablets
- Termination date
- Feb 8, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 1, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 24, 2020