Class III
Terminated
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.
This recall has been terminated (originally issued November 25, 2020).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- November 11, 2020
- Posted
- November 25, 2020
- Recall Number
- D-0100-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,088 cartons
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Distribution
Product was distributed Nationwide in the USA.
Lot / Code Info
Lot Number: 1351104, Exp 08/2021
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