Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP 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
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
suntegrity
CGMP Deviations
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Cloderm (clocortolone pivalate)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Gordofilm Wart Remover
cGMP Deviations
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
PROBLEND Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven Hand Sanitizer Gel
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven FOR GAS ISLAND USE ONLY
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND E3 Foaming Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
Pure Care Foaming Mint Hand Sanitizer 62%
CGMP Deviations
Class II · Moderate risk
Febuxostat Tablets
CGMP Deviations
Class II · Moderate risk
Omeza Skin Protectant
CGMP Deviations
Class II · Moderate risk
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Oxygen
cGMP Deviations
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk
Integrity Biochem HSC 70-VA
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
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