Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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
Paroxetine HCL Controlled-Release Tablets 12.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I · High risk
REUMOFAN PLUS Tablets
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Class II · Moderate risk
Fluoxetine Capsules
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class I · High risk
Meizitang Strong Version Botanical Slimming
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Magic Slim capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Slim Xtreme Weight loss capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Meizi Evolution Soft Gel Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
SlimEasy Herbs Capsule
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Class I · High risk
Pill for weight reduction
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Class I · High risk
Super Fat Burning Bomb Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
Class I · High risk
Fruta BIO 400 mg capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Class I · High risk
JIANFEIJINDAN Activity Girl Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Class I · High risk
REDUCE WEIGHT FRUTA PLANTA Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Class I · High risk
Xzen Platinum
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
ExtenZe 600 mg
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Magic For Men
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
MiracleZEN Platinum
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Sexy Monkey
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Boost Ultra
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Xzone Gold
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Burn 7 Capsules
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Class I · High risk
Dream Body Slimming Capsule
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
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