What is Formula 82F?
Formula 82F is a hair loss treatment that contains 5% Minoxidil, .25% Finasteride, and a topical steroid. Finasteride is a 5α-reductase inhibitor that works by decreasing the production of Dihydrotestosterone (DHT) in tissues in the scalp. Minoxidil is a solution used to help hair growth in the treatment of male pattern baldness.
What’s the Problem?
An FDA inspection of MasterPharm’s manufacturing plant found conditions that violated the Food Drug and Cosmetic Act or related governing Acts, including:
- The ISO classified aseptic processing areas have difficult to clean, particle-generating and visibly dirty equipment and surfaces.
- Non-microbial contamination was observed in the production area.
- Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
- The facility design allowed the influx of poor quality air into a higher classified area.
Which Lots Are Being Recalled?
This recall affects:
- Formula 82F (Minoxidil/Tretinoin/Fluocinolone
Acetonide/Finasteride)
Lot Number 01-15-2020:70@3 – Beyond Use Date 7/7/2020 - Formula 82F
(Minoxidil/Tretinoin/Fluocinolone/Finasteride)
Lot Number 01-09-2020:48@2 – Beyond Use Date 7/7/2020 - Formula 82F
(Minoxidil/Tretinoin/Fluocinolone/Finasteride)
Lot Number 01-20-2020:79@11 – Beyond Use Date 7/18/2020 - Formula 82F
(Minoxidil/Tretinoin/Fluocinolone/Finasteride)
Lot Number 01-23-2020:55@11 – Beyond Use Date 7/18/2020 - Formula 82F
(Minoxidil/Tretinoin/Fluocinolone/Finasteride)
Lot Number 01-29-2020:18@1 – Beyond Use Date 7/26/2020 - Formula 82F
(Minoxidil/Tretinoin/Fluocinolone/Finasteride)
Lot Number 02-03-2020:89@8 – Beyond Use Date 7/26/2020
These recalled drugs were distributed nationwide between January 13, 2020, and June 26, 2020, FDA said.
Formula 82F Side Effects
- Sexual side effects
- Scalp appearing more pink than usual (due to increased blood flow from the treatment)
- Redness
- Dryness
- Flaking
- Inflammation
- Discomfort of the scalp
Do I Have a Formula 82F Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Formula 82F Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by Formula 82F, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.