Class I - Dangerous
Subpotent Drug
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Qualitest Pharmaceuticals
Class I - Dangerous
Failed tablet specifications: One lot was found to contain oversized tablets.
Class I - Dangerous
Labeling: Illegible label. Writing is rubbing off of labels.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Class I - Dangerous
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I - Dangerous
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class I - Dangerous
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
Sun Pharma Global Fze
Class I - Dangerous
Failed Dissolution Specifications: 6 month time point.
Class I - Dangerous
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 - Dangerous
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class I - Dangerous
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Class I - Dangerous
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Acyclovir various strengths in normal saline
Walgreens Infusion Services
Class I - Dangerous
Lack of sterility assurance.