Class III · Low risk
Tarina Fe 1/20
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Chemical contamination & hidden ingredients
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.
709 FDA drug recalls with this cause, newest first.
This category covers two things the label never mentions. One is chemical contamination: benzene in sunscreens and hand sanitizers, methanol in sanitizer, lead or other heavy metals in a finished product. The other is a 'supplement' that secretly contains a prescription drug - sildenafil, tadalafil, sibutramine, phenolphthalein - so that it appears to work, at the cost of dangerous interactions the buyer cannot anticipate. A large share of these recalls are Class I, because the hidden ingredient is the whole risk.
Class II · Moderate risk
Calcipotriene Cream 0.0005%
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Class I · High risk
SLIMFIT X capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class I · High risk
MegaJex Herbal Supplement
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Class I · High risk
Ultimate Body Tox PRO capsules
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Skinny Bee Diet capsules
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Class III · Low risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class II · Moderate risk
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class III · Low risk
Hyoscyamine Sulfate Sublingual Tablets
Chemical Contamination: Bottles may contain broken dessicants
Class I · High risk
Super Samurai-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ginseng Power-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ninja-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Tiger-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class II · Moderate risk
Coppertone SUNSCREEN LOTION
Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk
3rd DEGREE capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK GOLD X ADVANCED capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK LABEL X capsules
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class II · Moderate risk
Cisatracurium Besylate Injection
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk
Potassium Chloride Injection 20 mEq
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Mannitol I.V.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Aminosyn-PF
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
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