Recalls / Class III
Class IIID-1099-2017
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.
- Affected lot / code info
- Lot #: 280318, Exp 03/28/2018; 020918, Exp 09/02/2018; 131019, Exp 10/13/19
Why it was recalled
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recalling firm
- Firm
- Linde Eckstein Gmbh + Co KG
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Flurstrasse 27a-35, N/A, Oberasbach, N/A N/A, Germany
Distribution
- Quantity
- 73 balms
- Distribution pattern
- Distributed throughout the United States
Timeline
- Recall initiated
- 2017-07-17
- FDA classified
- 2017-08-17
- Posted by FDA
- 2017-08-23
- Terminated
- 2018-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1099-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.