FDA Recall D-0637-2024
Teva Pharmaceuticals USA, Inc · Parsippany, NJ
Class II Ongoing 644 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Reason for recall
Superpotent Drug
Recall record
- Recall number
D-0637-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed nationwide within the United States
- Recall initiated
- 2024-08-08
- Classified by FDA Center
- 2024-08-16
- FDA published
- 2024-08-28
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- TESTOSTERONE
- Generic name(s)
- TESTOSTERONE
- Manufacturer(s)
- Actavis Pharma, Inc.
- NDC(s)
0591-2924, 0591-2925, 0591-2926- Route(s)
- TRANSDERMAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.