Class II · Moderate risk
(Malin + Goetz) Salicylic Gel
GMP Deviations
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
Class II · Moderate risk
DCL T Shampoo for Hair and Body
GMP Deviations
Class II · Moderate risk
DCL SA Scalp Therapy Shampoo
GMP Deviations
Class II · Moderate risk
DCL AHA Lightening Gel
GMP Deviations
Class II · Moderate risk
DCL B Prox10 Anti-Blemish Wash
GMP Deviations
Class II · Moderate risk
DCL Active Mattifying Cleanser
GMP Deviations
Class II · Moderate risk
Nature-Throid 1 GR
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Class II · Moderate risk
Genesis Hand Sanitizer Gel
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk
Genesis Hand Sanitizer Gel
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk
Panagel Hand Sanitizer
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk
Eye Itch Relief
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Class II · Moderate risk
Protz real protection Antibacterial Hand Sanitizer
Lack of CGMPs:
Class II · Moderate risk
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
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