Drug product
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
D-0034-2018
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 78143
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48 cartons (30 foil packets per carton)
- Official record key
drug-enforcement:D-0034-2018
Official wording
Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Code information: Lot: D60010A, EXP. 01/2019
Distribution pattern: AZ
Derived failure modes
-
Unknown
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.