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.
CeraVe Healing Lip Balm/SPF 30
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Drug: Octisalate
- Recalling firm
- Product Quest Manufacturing LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0071-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Octisalate 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 I · High risk
Coppertone SPORT Sunscreen Spray 50
Chemical contamination; presence of benzene
Other recalls by Product Quest Manufacturing LLC
All 2018 recalls
Class II · Moderate risk
Family Dollar Saline Nasal Spray 4.25 oz. can
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Finafta Baby
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rexall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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