Is Ambi Fade cream discontinued? Twelve businesses received a warning letter from the F.D.A. It is for marketing over-the-counter (O.T.C.) skin-lightening items. Those items are incompatible enough to be offered as O.T.C. medications containing hydroquinone. The warning letters clarify how these over-the-counter skin-lightening solutions, which contain the drug hydroquinone as an active ingredient, are not permitted. As a result, they are not accepted as being secure and efficient.
Ambi Fade Cream Normal and Ambi Fade Cream Oily are being discontinued. Each had 2% hydroquinone in the composition. According to the F.D.A., hydroquinone items may no longer be purchased over the counter. Only a dermatologist with a license and board certification may offer it. Let us know about it further in this article.
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Is there a recall on AMBI?
The O.T.C. drug AMBI Fade is made, distributed, or branded by Valeant Pharmaceuticals North America L.L.C. and Accupac, Inc. This product serves as both a sunscreen and a skin-bleaching agent. It is used to lighten dark skin defects like freckles, age spots, liver spots, or pigment that may develop during pregnancy or from using contraceptive pills. It has sunscreen in it to help avoid new discoloration. Two percent of hydroquinone and two percent of octinoxate are the product’s active components.
On April 19, 2022, the F.D.A. alerted 12 businesses. This is for marketing over-the-counter (O.T.C.) skin-lightening products containing hydroquinone. Due to the possible risk, they may cause ochronosis, which may be lifelong. Thus, the F.D.A. cautions consumers not to use these items. Hence, consumers should discuss their choices for treating specific skin issues. This includes aging or dark spots with their healthcare provider.
Family Dollar had started a voluntary product recall of a select group of products. This was governed by the U.S. Food and Drug Administration (F.D.A.). They supplied them and kept them at a select number of locations from about April 5, 2022, through the present. This is because the products were stored beyond the specified temperature limits. Family Dollar is unaware of any customer complaints or sickness reports connected to this recall. The following products are included in this retail-level recall:
- AMBI Exfoliating Wash 5 OZ
- AMBI Skin Cream, Normal, 2 FL OZ
- AMBI Skin Cream Oily 2 FL OZ
- AMBI Nourishing Daily Facial Moisturizer 1.7 OZ
Violations of Misbranded Drugs
According to Section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1), Ambi Skincare Fade Cream for Oily Skin and Ambi Skincare Fade Cream for Normal Skin are both drugs. This is because they are meant to be used in the diagnosis, treatment, mitigation, or prevention of sickness. Because they are meant to alter the structure or function of the body, they fall under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C). These items are specially built to be used as skin-bleaching goods.
Ambi Skincare Fade Cream for Oily Skin and Ambi Skincare Fade Cream for Normal Skin products are misbranded. These are unapproved new drugs. They are supplied for introduction into interstate trade in violation of Section.
F.D.A. Alerts for AMBI Fade
The F.D.A. has received reports of severe bad reactions from using skin-lightening products containing hydroquinone. This includes skin rashes, facial swelling, and skin discoloration. The adverse effects could be irreversible.
The F.D.A. is warning customers that no O.T.C. skin-lightening items have received F.D.A. approval or have been legally advertised. The F.D.A. is taking legal action against individuals selling these hazardous and illegal O.T.C. skin-whitening treatments. It’s even though some makers and distributors have already pulled them off the shelves.
To avoid importing certain products, the F.D.A. has added a few makers of skin-lightening treatments to an import notice. Hydroquinone use in cosmetic items is subject to many of the same safety concerns raised by the F.D.A. This is about its usage in O.T.C. skin-lightening medication products.
The F.D.A. reminds producers and distributors that it is their job to ensure their products meet all legal and regulatory requirements. Also, they should follow federal standards for safety and efficacy. F.D.A. action is possible for those who violate the rules.