Recalls / Class II
Class IID-1289-2022
Product
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Topical
- NDCs
- 0591-2921, 0591-3216, 0591-3217
- FDA application
- ANDA076737
- Affected lot / code info
- Lot: 1403180, EXP. 10/2022
Why it was recalled
Superpotent Drug: Out of specification assay result was obtained during stability testing.
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
- Quantity
- 12354 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-07-25
- Posted by FDA
- 2022-08-03
- Terminated
- 2024-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1289-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.