Class I · High risk
Heparin Sodium
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
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
Bupivacaine HCl Inj.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class I · High risk
Dianeal Low Calcium
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Class II · Moderate risk
ProSol - sulfite-free
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class I · High risk
Potassium Chloride Injection
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Class II · Moderate risk
Metoprolol Succinate Extended-release Tablets
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class II · Moderate risk
Brevibloc Premixed Injection
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Class II · Moderate risk
Atorvastatin Calcium 40 MG Tablet
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Class II · Moderate risk
Cefpodoxime Proxetil Tablets
Presence of Foreign Substance: Presence of stainless steel particles.
Class II · Moderate risk
Ciprofloxacin 500 mg tablets
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Class II · Moderate risk
Mesalamine
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class I · High risk
Coumadin for Injection
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Class I · High risk
0.9 % Sodium Chloride Injection
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Class II · Moderate risk
PROMETHAZINE HYDROCHLORIDE Tablets
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
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