Class II · Moderate risk
Testosterone Regular Release 200 MG
CGMP Deviations: Potential presence of metal particulate matter
Particulate & foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
867 FDA drug recalls with this cause, newest first.
These recalls involve visible foreign material - glass, metal, fibers, rubber or other debris - most often found in injectable or liquid products, where nothing besides the intended ingredients should be present. It also includes foreign tablets or capsules found in a bottle of a different product. In an injectable a stray particle can go straight into the bloodstream, which is why a noticeable share of these recalls are Class I.
Class II · Moderate risk
Testosterone Regular Release 50 MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 200 MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 87.5 MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 62.5 MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 50MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 25MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim
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
Sulfamethoxazole and Trimethoprim
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
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 at the manufacturing site, 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 at the manufacturing site, 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
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
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
Dextroamphetamine Saccharate
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
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.
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