D-0100-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2020
- Initiation Date
- November 11, 2020
- Termination Date
- June 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,088 cartons
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.
Reason for Recall
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Distribution Pattern
Product was distributed Nationwide in the USA.
Code Information
Lot Number: 1351104, Exp 08/2021