Class III · Low risk
Pharmalucence Kit for the Preparation of Technetium Tc 99m…
Presence of Particulate Matter; particulate found in retain samples
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 I · High risk
Magnesium Sulfate Injection
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Class II · Moderate risk
Ondansetron Injection
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter: Found during examination of retention samples.
Class II · Moderate risk
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Class II · Moderate risk
Gentamicin Sulfate Injection USP 80 mg/2 mL
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Class II · Moderate risk
Amoxicillin Capsules USP 500 mg
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Ciprofloxacin Tablets USP
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Class I · High risk
Vistide (cidofovir)
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Class II · Moderate risk
Lansoprazole Delayed-release Capsules
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class II · Moderate risk
Terazosin Hydrochloride Capsules
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class II · Moderate risk
Prednisone tablets
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Class II · Moderate risk
Propylthiouracil Tablets
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Class II · Moderate risk
PredniSONE Tablets
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
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