Why it was recalled
Superpotent Drug
Product description
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Lot numbers, UPCs & expiration codes
Lot #: 100042386, Exp. Date 06/2025
Where it was sold
Product was distributed nationwide within the United States
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-0637-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 8, 2024
- FDA report date
- Aug 28, 2024
- Quantity
- 7,080 unit dose packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0637-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95122
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100042386, Exp. Date 06/2025
- Postal code
- 07054-1120
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0637-2024
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 7,080 unit dose packets
- Reason for recall
- Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Aug 8, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2024