Why it was recalled
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 280318, Exp 03/28/2018; 020918, Exp 09/02/2018; 131019, Exp 10/13/19
Where it was sold
Distributed throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1099-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 17, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 73 balms
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Linde Eckstein Gmbh + Co KG
Original FDA data
Every field from FDA enforcement report D-1099-2017, exactly as published.
Show all FDA fields
- City
- Oberasbach
- Status
- Terminated
- Country
- Germany
- Event ID
- 77840
- Address
- Flurstrasse 27a-35
- Code information
- Lot #: 280318, Exp 03/28/2018; 020918, Exp 09/02/2018; 131019, Exp 10/13/19
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1099-2017
- Classification
- Class III
- Recalling firm
- Linde Eckstein Gmbh + Co KG
- Product quantity
- 73 balms
- Termination date
- Feb 28, 2018
- Reason for recall
- Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed throughout the United States
- Recall initiation date
- Jul 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2017