Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
FDA Drug Recalls
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Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
traMADOL Hydrochloride Tablets
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Class II · Moderate risk
Epinephrine Injection USP
Presence of Particulates; may contain glass particles
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; product may contain fibrous material
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Adulterated 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 III · Low risk
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin
Presence of Particulate Matter; potential for charcoal particulates
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class I · High risk
Trastuzumab Kit containing 1 vial Trastuzumab
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Class II · Moderate risk
Levetiracetam Tablets
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Class II · Moderate risk
OFIRMEV (acetaminophen)
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Class II · Moderate risk
Leucovorin Calcium Injection USP
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class III · Low risk
Nexium (esomeprazole magnesium)
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Class II · Moderate risk
Paclitaxel Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Methotrexate Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Cytarabine Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Carboplatin Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class I · High risk
Vecuronium Bromide for Injection
Presence of Particulate Matter
Class II · Moderate risk
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg)
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Class III · Low risk
Endocet (oxycodone and acetaminophen)
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Class II · Moderate risk
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Class II · Moderate risk
Epinephrine Injection
Presence of Particulate Matter