Recalls / Class III
Class IIID-0127-2024
Product
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
- 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 #: 100029472, Exp. 2/29/2024
Why it was recalled
OOS for viscosity
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Actavis Pharma, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-11-10
- FDA classified
- 2023-11-29
- Posted by FDA
- 2023-12-06
- Terminated
- 2024-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0127-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.