FDAFDA · Food and drugs·Recall number D-0100-2021
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.
Published November 25, 2020 · Recall initiated: November 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed Nationwide in the USA.
- Lot
- Lot Number: 1351104, Exp 08/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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