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Recall Observatory FDA recall evidence

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

March 05, 2025

Class II

Product summary

Firm
Strides Pharma, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance