621 recalls · Class II, newest first
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Presence of Particulate Matter.
Presence of Particulate Matter.
Presence of Particulate Matter.
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
GMP Deviations: A silicone particulate was noted in Ozurdex.
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Presence of Foreign Substance; metal shard found in tablet
Presence of foreign substance: Product found to contain metal particles.
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Presence of foreign substance: glass particles