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.
Reported: November 25, 2020 Initiated: November 11, 2020 #D-0100-2021
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 12,088 cartons
- Distribution
- Product was distributed Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 12,088 cartons.
Why was this product recalled? ▼
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2020. Severity: Low. Recall number: D-0100-2021.
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