What is Formula 82M?
Formula 82M is a prescription medication used for hair regrowth that is an alternative to the over-the-counter (OTC) generic minoxidil or Rogaine brand. The drug contains (5%) Minoxidil and Tretinoin, along with a topical steroid. Minoxidil is an active metabolite which has been shown in studies to stimulate hair growth. It has been the number one topical therapy for Androgenetic Alopecia (AGA) since receiving FDA clearance in 1988.
What’s the Problem?
The company that makes Formula 82M, South Richmond Hill, New York-based MasterPharm, LLC, has issued a recall for the hair loss treatment after an FDA inspection found at least 5 safety violations at its manufacturing facility. These violations included:
- 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 Products are Affected by this Recall?
- Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
01-13-2020:40@27 7/7/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
01-17-2020:45@4 7/7/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
01-31-2020:73@6 7/26/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
02-17-2020:86@5 8/10/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
01-21-2020:43@11 7/18/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
01-28-2020:88@15 7/26/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
02-12-2020:43@16 8/10/2020 - Formula 82M (Minoxidil/Tretinoin/Fluocinolone
Acetonide)
The recalled 82M was distributed nationwide between January 13, 2020, and June 26, 2020.
Formula 82M 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 82M Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Formula 82M 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 82M, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.