Agency classClass IIIOur severity:Low FDA (Drugs)·D-1099-2017·Announced 2017-08-23

Linde Eckstein Recalls Beautipharm Eye Care Balm Due to SPF Labeling Concerns

Linde Eckstein is recalling 73 bottles of Beautipharm Eye Care Balm SPF 10 because the sun protection factor claim cannot be fully guaranteed.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a labeling guarantee concern rather than a confirmed contamination or defect causing injury.

Plain-English summary

Linde Eckstein Gmbh + Co KG is recalling 73 bottles of Beautipharm Eye Care Balm SPF 10. The product is a 1 oz (30 ml) eye cream manufactured in Germany and distributed throughout the United States. The recall involves specific lots with expiration dates of 03/28/2018, 09/02/2018, and 10/13/2019.

The recall was initiated because the product is labeled as having SPF 10 protection, but the manufacturer states that this claim cannot be 100% guaranteed. This is classified as a subpotent drug issue.

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

The recalled product

Product: Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
Manufacturer: Linde Eckstein Gmbh + Co KG
Category: Drug — Topical Sunscreen
Hazard: mis-labeling
Affected units: 73

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 (6)

Lot #: 280318
Exp 03/28/2018
020918
Exp 09/02/2018
131019
Exp 10/13/19

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 14 recalled by Linde Eckstein Gmbh + Co KG 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 14 products in this recall →

Same manufacturer · Linde Eckstein Gmbh + Co KG

See all →

Low
Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein Recalls Beautipharm Body Moisturizing Balm Due to Subpotent SPF
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection
FDA (Drugs) · 2017-08-23
Low
Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim
FDA (Drugs) · 2017-08-23

Same hazard · mis labeling