Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
The Beast
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
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.
What was recalled
The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
- Recalling firm
- Stiff Boy LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1321-2019 · FDA notice
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other chemical / undeclared recalls from 2019
All chemical / undeclared recalls
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
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