Drug product
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
D-0293-2025
Product summary
- Event
- Event 96412
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 195,952 Cartons; 30 sachets/Carton.
- Official record key
drug-enforcement:D-0293-2025
Official wording
Reason: Presence of foreign substance: Presence of Benzene.
Code information: Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
Distribution pattern: Nationwide in the U.S
Derived failure modes
-
Foreign material or chemical contamination
foreign substance