Ohm Laboratories Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg recall — FDA D-0034-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or…
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Subpotent Drug
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility…
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Subpotent Drug: Salicylic acid is subpotent.
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