124 recalls · Class I, newest first
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Non-Sterility
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.