ZapMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I — High risk. Reasonable probability of serious harm or death.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Free recall alerts
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