FDA Drug recall D-0100-2021
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17)
- FDA Drug
- Class III
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class III recall of Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17) by Teva Pharmaceuticals Usa, citing superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0100-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
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
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Identifiers
| ndc | 0591-2921-18 |
|---|---|
| ndc | 0591-2921-02 |
| ndc | 0591-3216-17 |
| ndc | 0591-3216-30 |
| ndc | 0591-3217-26 |
| ndc | 0591-3217-30 |
| code_info | Lot Number: 1351104, Exp 08/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0100-2021%22
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