FDA recall D-1099-2017

Linde Eckstein Gmbh + Co KG · Class III · 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.

Reason for recall

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

Distribution

Distributed throughout the United States

Key facts

Status
Terminated
Initiation date
2017-07-17
Report date
2017-08-23
Termination date
2018-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oberasbach, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1099-2017