Class II · Moderate risk Ongoing
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Reason Lack of Assurance of Sterility
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
What was recalled
XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
- Recalling firm
- Nova Products, Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1602-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Gold recalls
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Class II · Moderate risk Ongoing
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5…
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class II · Moderate risk Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM…
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
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