The Recall Desk
ModerateFDA (Drugs)·D-0813-2018·Announced 2018-05-23

Milbar Recalls Naturmetic Sunscreen Due to Manufacturing Deviations

Milbar Laboratories is recalling 4,815 tubes of Naturmetic SPF 50 Sunscreen due to Good Manufacturing Practice (GMP) deviations.

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 due to GMP deviations, which typically corresponds to a moderate severity level involving potential but not immediate serious harm.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 4,815 tubes of Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles. The product was distributed within the United States and Puerto Rico. The specific lot affected is KU455-4, with an expiration date of 10/30/2020.

The recall was initiated on May 4, 2018, due to Good Manufacturing Practice (GMP) deviations. The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was terminated on June 26, 2019.

Consumers who have this product should stop using it and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Sunscreen
Hazard
Affected units
4,815

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 (2)

  • Lot #: KU455-4
  • Exp.10/30/2020

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Milbar Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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