Class I - Dangerous
GMP deviation; Sr-82 levels exceeded alert limit specification
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Prescription Drugs
💊 Drugs • 12,141 recalls
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Class I - Dangerous
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class I - Dangerous
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Mylan Pharmaceuticals
Class I - Dangerous
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
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 I - Dangerous
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Class I - Dangerous
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 I - Dangerous
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 - Dangerous
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class I - Dangerous
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 I - Dangerous
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class I - Dangerous
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Class I - Dangerous
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
Microbial Contamination of Non Sterile Product; mold