Why it was recalled
OOS for viscosity
Product description
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Lot numbers, UPCs & expiration codes
Lot #: 100029472, Exp. 2/29/2024
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0127-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 10, 2023
- FDA report date
- Dec 6, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0127-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93409
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100029472, Exp. 2/29/2024
- Postal code
- 07054-1120
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0127-2024
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Termination date
- Jun 3, 2024
- Reason for recall
- OOS for viscosity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
- Distribution pattern
- USA nationwide
- Recall initiation date
- Nov 10, 2023
- Center classification date
- Nov 29, 2023