D-1289-2022 Class II Terminated
FDA drug recall D-1289-2022 was initiated by Teva Pharmaceuticals USA Inc on Jun 29, 2022 and is designated Class II. Reason for recall: Superpotent Drug: Out of specification assay result was obtained during stability testing. The recall status is terminated (terminated Mar 15, 2024). Affected quantity: 12354 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 3, 2022
- Initiation Date
- Jun 29, 2022
- Termination Date
- Mar 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12354 cartons
Product Description
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Reason for Recall
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 1403180, EXP. 10/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1289-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026