Class II · Moderate risk
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Labeling: Missing instructions for use insert
Skin Medica Acne System
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
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
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
- Recalling firm
- Allergan PLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1410-2020 · 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 recalls by Allergan PLC
All 2020 recalls
Class III · Low risk
Skin Medica Acne Treatment Lotion
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class II · Moderate risk
INFed (Iron Dextran Injection USP)
Failed Stability Specification: out of specification for iron content.
Other wrong potency / content recalls from 2020
All wrong potency / content recalls
Class II · Moderate risk
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
Class II · Moderate risk
UVT World Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
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