Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc…
Teva Pharmaceuticals USA, Inc · Defective Container - A defect in the side-seal which allows leakage of product.
- Status
- Ongoing
- City
- Parsippany
- State
- NJ
- Country
- United States
- Classification
- Class III
- Product type
- Drugs
- Event ID
- 97944
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Address 1
- 400 Interpace Pkwy Bldg A
- Postal code
- 07054-1120
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
- Recall number
- D-0198-2026
- Product quantity
- 15,944 cartons
- Reason for recall
- Defective Container - A defect in the side-seal which allows leakage of product.
- Recall initiation date
- 20251107
- Center classification date
- 20251201
- Report date
- 20251210
- Code info
- Lot #100068692, Exp.: 04/30/2027
- Product description
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
- Harmonized identifiers (openFDA)
- Application number
- ANDA076737
- Brand name
- TESTOSTERONE
- Generic name
- TESTOSTERONE
- Manufacturer name
- Actavis Pharma, Inc.
- Product NDC
- 0591-2921, 0591-3216, 0591-3217
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Substance name
- TESTOSTERONE
- RxCUI
- 1596780, 1597123, 1597129
- SPL ID
- 38f554a5-ee64-4429-96c5-52b02c7763c1
- SPL set ID
- 5834d34f-839d-412c-b74c-da1dad2cfa88
- Package NDC
- 0591-2921-18, 0591-2921-02, 0591-3216-17, 0591-3216-30, 0591-3217-26, 0591-3217-30
- Is original packager
- true
- Nui
- N0000175824, N0000000146, M0001109
- Pharm class epc
- Androgen [EPC]
- Pharm class moa
- Androgen Receptor Agonists [MoA]
- Pharm class cs
- Androstanes [CS]
- UNII
- 3XMK78S47O