MICHIGAN HERBAL REMEDIES A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 recall — FDA D-1456-2020
Chemical contamination: product contains elevated levels of undeclared lead.
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.
10,685 detailed records are currently available in this category.
Chemical contamination: product contains elevated levels of undeclared lead.
cGMP deviations
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Microbial contamination of non-sterile products: positive microbial contamination in product.
Chemical contamination: product contains elevated levels of undeclared lead.
Chemical contamination: product contains elevated levels of undeclared lead.
Lack of Processing Controls (lack of assurance of conformity to specifications).
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Chemical Contamination: Product contains undeclared methanol.
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
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