Class II · Moderate risk
DermaCerin
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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Class II · Moderate risk
4-N-1 Skin Protectant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation USP. Isotonic Solution for Irrigation
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class III · Low risk
TopCare Health 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class III · Low risk
Kroger 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
Class II · Moderate risk
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50…
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk
Ultra Violette
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Class II · Moderate risk
Carvedilol Tablets USP
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class III · Low risk
Readyprep Pvp
Subpotent drug
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter.
Class I · High risk
Lactated Ringers's Injection USP
Presence of Particulate Matter
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class II · Moderate risk
Tavaborole Topical Solution 5%
Discoloration
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II · Moderate risk
Theophylline extended-release tablets 400mg
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.