The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0628-2018·Announced 2018-04-25

Marcas Usa Recalls Zinc Oxide Cream Due to Microbial Contamination

Marcas Usa Llc is recalling specific lots of PASTA DE LASSAR ANDROMACO Skin Protection cream due to microbial contamination.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health impact).

Plain-English summary

Marcas Usa Llc is voluntarily recalling specific lots of PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tubes. The recall is being conducted because the product has been found to be contaminated with microorganisms.

The affected product is identified by NDC #75940-111-60 and UPC #851357003004. The recall covers 69,238 tubes distributed in Texas. The specific lot numbers and expiration dates involved are 15PL041 (Exp. 04/18), 15PL040 (Exp. 04/18), 15PL039 (Exp. 05/18), and 17LP117 (Exp. 10/20).

Consumers who have purchased these specific lots should stop using the product and contact the manufacturer for a refund or replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
Manufacturer
Marcas Usa Llc

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 (5)

  • Lot Number(s): 15PL041
  • Exp. 04/18 15PL040
  • Exp. 04/18 15PL039
  • Exp. 05/18 17LP117
  • Exp. 10/20

Distribution

Distributed in 1 state:

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