FDA Drug recall D-0033-2018
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Onl…
- FDA Drug
- Class III
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class III recall of AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Onl… by Abbvie, citing temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0033-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-08 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Abbvie |
| Distribution | AZ |
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
Reason
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Identifiers
| code_info | Lot: 91122, EXP. 01/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0033-2018%22
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