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Recall Observatory FDA recall evidence

Drug product

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

D-0294-2025

March 05, 2025

Class II

Product summary

Firm
Strides Pharma, Inc.
Event
Event 96412
Status
Ongoing
Classification
Class II
Quantity
244,412 Cartons; 30 sachets /Carton
Official record key
drug-enforcement:D-0294-2025

Official wording

Reason: Presence of foreign substance: Presence of Benzene.

Code information: Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.

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