AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
AbbVie Inc. is recalling AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, NDC 0051-8462-33. The recall involves 520 pumps from Lot 91122 with an expiration date of 01/2020. The product was distributed in Arizona.
The recall was initiated due to temperature abuse, specifically prolonged exposure to temperatures outside of the labeled storage conditions. This deviation from storage requirements may impact the quality or stability of the medication.
Consumers who have this specific lot of AndroGel should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- 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
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Testosterone Gel
- Hazard
- Affected units
- 520
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 91122
- EXP. 01/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by AbbVie Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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