Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Beautipharm Eye Care Balm SPF 10
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Drug: Octocrylene
- Recalling firm
- Linde Eckstein Gmbh + Co KG
- Origin
- N/A, Germany
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1099-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Octocrylene recalls
See all
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Other recalls by Linde Eckstein Gmbh + Co KG
All 2017 recalls
Class III · Low risk
Make Up Perfect terra
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect dark tan
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect sand
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk
Make Up Perfect pastel
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
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