Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
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
Fosphenytoin Sodium Injection
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
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
0.9% Sodium Chloride Irrigation
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class II · Moderate risk
Pristiq (desvenlafaxine)
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class II · Moderate risk
LOSARTAN POTASSIUM Tablets
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Class II · Moderate risk
Tikosyn¿ (dofetilide)
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
Class I · High risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Class II · Moderate risk
Potassium Chloride for Inj. Concentrate
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Class II · Moderate risk
Polidocanol 3% Solution
Presence of Particulate Matter
Class I · High risk
VPRIV¿ (velaglucerase alfa for injection)
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Class II · Moderate risk
Perrigo
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
Class I · High risk
Venlafaxine HCl Extended-Release Capsules
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Class I · High risk
Effexor XR
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Class III · Low risk
Atripla
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Class I · High risk
Acetylcysteine Solution
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Class II · Moderate risk
etomidate injection
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Class II · Moderate risk
BUPivacaine HCl 0.25% Preservative Free
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.
Class II · Moderate risk
Bupivacaine HCl Inj. USP
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
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