Recalls / Class II
Class IID-0637-2024
Product
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
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Transdermal
- NDCs
- 0591-2924, 0591-2925, 0591-2926
- FDA application
- ANDA204570
- Affected lot / code info
- Lot #: 100042386, Exp. Date 06/2025
Why it was recalled
Superpotent Drug
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 7,080 unit dose packets
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2024-08-08
- FDA classified
- 2024-08-16
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0637-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.