Class III · Low risk Terminated
Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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Class III · Low risk Terminated
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Good to Go Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class III · Low risk Terminated
Clonidine HCL Injection
Reason Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Class I · High risk Terminated
Lidocaine HCl Injection
Reason Presence of Particulate Matter: One vial was found to contain a hair.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III · Low risk Terminated
Thallous Chloride TI 201 Injection
Reason Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class II · Moderate risk Terminated
Phenobarbital Oral Solution
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk Terminated
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP
Reason Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class III · Low risk Terminated
Biotin 10 mg/mL Injection
Reason Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk Terminated
Fayosim
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class II · Moderate risk Terminated
Gavilyte-N
Reason Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk Terminated
Combigan
Reason cGMP Deviations
Class III · Low risk Terminated
Diclofenac Sodium Topical Solution
Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk Terminated
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Reason Defective container: Ineffective seal between the cap and jar of the affected product.