Why it was recalled
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Product description
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Lot numbers, UPCs & expiration codes
Lot: 1403180, EXP. 10/2022
Where it was sold
Nationwide in the USA
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-1289-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 12354 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1289-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90534
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot: 1403180, EXP. 10/2022
- Postal code
- 07054-1120
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1289-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 12354 cartons
- Termination date
- Mar 15, 2024
- Reason for recall
- Superpotent Drug: Out of specification assay result was obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 29, 2022
- Center classification date
- Jul 25, 2022