Advance Hand Sanitizer
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
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Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Reason Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Reason Subpotent and Presence of Particulates .
Reason Subpotent Drug
Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Reason Presence of foreign substance: identified as activated carbon.
Reason 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
Reason 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
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Presence of Foreign Tablet/Capsule
Reason Subpotent Drug
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Reason Temperature Abuse: Product exposed to temperature outside specified limits.