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Recall Observatory FDA recall evidence

Drug 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.

D-1099-2017

July 17, 2017

Class III

Product summary

Firm
Linde Eckstein Gmbh + Co KG
Event
Event 77840
Status
Terminated
Classification
Class III
Quantity
73 balms
Official record key
drug-enforcement:D-1099-2017

Official wording

Reason: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

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

Distribution pattern: Distributed throughout the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent