Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380…
Strides Pharma, Inc. · Presence of foreign substance: Presence of Benzene.
- Status
- Completed
- City
- Chestnut Ridge
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96412
- Recalling firm
- Strides Pharma, Inc.
- Address 1
- 1 Ram Ridge Rd
- Address 2
- N/A
- Postal code
- 10977-6714
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S
- Recall number
- D-0294-2025
- Product description
- 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
- Product quantity
- 244,412 Cartons; 30 sachets /Carton
- Reason for recall
- Presence of foreign substance: Presence of Benzene.
- Recall initiation date
- 20250305
- Center classification date
- 20250325
- Report date
- 20250402
- Code info
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.
- Harmonized identifiers (openFDA)
- Application number
- ANDA076744
- Brand name
- TESTOSTERONE
- Generic name
- TESTOSTERONE
- Manufacturer name
- Strides Pharma Science Limited
- Product NDC
- 64380-151, 64380-152
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TRANSDERMAL
- Substance name
- TESTOSTERONE
- RxCUI
- 1597123, 1597129
- SPL ID
- 6d50f17e-4607-458a-882b-620daa3b58a9
- SPL set ID
- ee54c393-bcfe-4a52-b7b3-1da8750f35d9
- Package NDC
- 64380-152-01, 64380-152-02, 64380-151-01, 64380-151-02
- Is original packager
- true
- Upc
- 0364380151012, 0364380152019
- Nui
- N0000175824, N0000000146, M0001109
- Pharm class epc
- Androgen [EPC]
- Pharm class moa
- Androgen Receptor Agonists [MoA]
- Pharm class cs
- Androstanes [CS]
- UNII
- 3XMK78S47O