Recalls / Class III
Class IIID-0033-2018
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
- Affected lot / code info
- Lot: 91122, EXP. 01/2020
Why it was recalled
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, N/A, North Chicago, Illinois 60064-1802
Distribution
- Quantity
- 520 pumps
- Distribution pattern
- AZ
Timeline
- Recall initiated
- 2017-09-08
- FDA classified
- 2017-10-25
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0033-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.