Why it was recalled
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Product description
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Lot numbers, UPCs & expiration codes
Lot Number: 1351104, Exp 08/2021
Where it was sold
Product was distributed 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-0100-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 11, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 12,088 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0100-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86738
- Address
- 400 Interpace Pkwy
- Code information
- Lot Number: 1351104, Exp 08/2021
- Postal code
- 07054-1120
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0100-2021
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 12,088 cartons
- Termination date
- Jun 24, 2021
- Reason for recall
- Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
- Distribution pattern
- Product was distributed Nationwide in the USA.
- Recall initiation date
- Nov 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2020