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.
FDA Drug Recalls
638 recalls, newest first
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.
Class II · Moderate risk
Guaifenesin USP
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Class I · High risk
DOBUTamine Injection
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.