The Recall Desk
ModerateFDA (Drugs)·D-0084-2018·Announced 2017-11-29

FDA Recalls Unapproved Faiza Beauty Cream Distributed in New York

The FDA is recalling No. 1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report specific injuries or illnesses, aligning with a Moderate severity rating for unapproved drug marketing.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling No. 1 Faiza Beauty Cream. The product was manufactured by Poonia Brothers (Pak) in Gujranwala and distributed by Shata Traders Inc. in Brooklyn, New York. The recall involves 96 foil packages with Batch # 16L63 and Lot # 223190.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This classification indicates that the product is an unapproved new drug.

Consumers who have purchased this product should stop using it and contact the distributor, Shata Traders Inc., for further instructions.

The recalled product

Product
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
Affected units
96

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 (1)

  • Batch # 16L63 Lot # 223190

Distribution

Distributed in 1 state: