Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
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Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 100 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
temper tamer
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Infuvite Adult
Reason Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk Ongoing
Medroxyprogesterone Acetate Injectable Suspension
Reason Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Lubricant Eye Drops Solution
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Artificial Tears Ophthalmic Solution
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Clindamycin HCl Capsule
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk Ongoing
Benlysta
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Evenity
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Prolia
Reason CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk Ongoing
Tirofiban Hydrochloride Injection 12.5 mg/250 mL
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk Ongoing
Tirofiban Hydrochloride Injection 5 mg/100 mL
Reason Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations
Class I · High risk Ongoing
Ropivacaine Hydrochloride Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
FentaNYL 500mcg
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexonto 0.4%
Reason Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class I · High risk Ongoing
Male Ultra Pro
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Ultra Armor
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.