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Drug Recalls

Drug Recall Results

Semglee – Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens

Date: 01/19/2022
Company: Mylan Pharmaceutical Inc.
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Missing Label
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CHANTIX – Varenicline tablets

Date: 09/16/2021
Company: Pfizer
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: N-nitroso-varenicline above acceptable daily intake level
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Imperial – Dietary Supplement for Male Enhancement

Date: 03/25/2021
Company: S&B Shopper LLC
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil & Tadalafil
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GUM Paroex – Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups

Date: 12/31/2020
Company: Precision Dose Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Potential contamination with Burkholderia lata
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Time-Cap Labs Inc. – Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg

Date: 10/05/2020
Company: Marksans Pharma Limited
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
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Riomet ER – Metformin Hydrochloride for Extended-Release Oral Suspension

Date: 09/23/2020
Company: Sun Pharmaceutical Industries
Dosage Form: Suspension
Recall Issue Type: Other Recall Issue
Recall Reason: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
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V-Klean, Medical Minded, Protz – Hand Sanitizer

Date: 08/25/2020
Company: Asiaticon SA de CV
Dosage Form: Other / Unspecified
Recall Issue Type: Quality / Potency
Recall Reason: Potential presence of methanol (wood alcohol) and subpotent ethanol levels
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Bayshore Pharmaceuticals, LLC – Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg

Date: 08/20/2020
Company: Bayshore Pharmaceuticals, LLC
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
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FLORANCE MORRIS – Antiseptic Hand Sanitizer, 70% Alcohol

Date: 08/20/2020
Company: Grupo Asimex de Mexico SA de CV
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Potential Methanol Contamination
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Nuuxsan, Modesa, more – Hand Sanitizer

Date: 08/18/2020
Company: ALBEK de Mexico S.A. de C.V.
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol
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Gelbac T – Antibacterial Handgel

Date: 08/07/2020
Company: Incredible Products Sa de Cv
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Methanol Contamination
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Command Brands – Hand Sanitizer

Date: 08/04/2020
Company: Roque Plast S.A. de C.V.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Methanol Contamination
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Jaloma – Hand Sanitizer

Date: 08/01/2020
Company: Laboratorios Jaloma S.A. de C.V.
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol
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Herbacil – Hand Sanitizer

Date: 07/28/2020
Company: Broncolin S.A. de C.V
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol
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Assured, Blumen, Modesa – Hand Sanitizer

Date: 07/27/2020
Company: 4e Brands North America
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol
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Resource Recover & Trading, LLC – Hand Sanitizer

Date: 07/27/2020
Company: Resource Recovery & Trading, LLC
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol subpotency ethyl alcohol
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Born Basic, Scent Theory and more – Hand Sanitizer

Date: 07/24/2020
Company: Real Clean Distribuciones SA de CV
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared methanol
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Optimus – Hand Sanitizer

Date: 07/20/2020
Company: LIQ-E S.A. de C.V.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Potential Methanol Contamination
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Blumen – Hand Sanitizer

Date: 07/13/2020
Company: 4e Brands North America
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Methanol
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Lupin – Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg

Date: 07/08/2020
Company: Lupin Pharmaceuticals, Inc.
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: N-Nitrosodimethylamine (NDMA) Impurity
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