Drug product
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
D-0033-2018
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 78143
- Status
- Terminated
- Classification
- Class III
- Quantity
- 520 pumps
- Official record key
drug-enforcement:D-0033-2018
Official wording
Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Code information: Lot: 91122, EXP. 01/2020
Distribution pattern: AZ
Derived failure modes
-
Unknown
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.