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Valeant Pharmaceuticals North America LLC

Valeant Pharmaceuticals North America LLC Recalls

All product recalls associated with Valeant Pharmaceuticals North America LLC.

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Recall Summary

Total Recalls

25

Past Year

0

Class I (Serious)

0

Most Recent

Jan 2019

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 25 recalls

Cardizem CD 120mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 240mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Diltiazem HCl CD 360mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

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Class IIILow

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 300mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 180mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cortaid Maximum Strength Cream (Valeant) – Microbial Contamination (2018)

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

Class IIModerate

FDAAug 24, 2018Nationwide• Valeant Pharmaceuticals North America LLC

Cortaid Anti-itch Cream (Valeant) – Microbial Contamination (2018)

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

Class IIModerate

FDAAug 24, 2018Nationwide• Valeant Pharmaceuticals North America LLC

Cortaid Cooling Spray (Valeant) – Microbial Contamination (2018)

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

Class IIModerate

FDAAug 24, 2018Nationwide• Valeant Pharmaceuticals North America LLC

Diazepam Rectal Gel (Valeant) – Incorrect Labeling (2018)

Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.

FDAJul 10, 2018Nationwide• Valeant Pharmaceuticals North America LLC

C-Therapy Night Cream (Valeant) – Incomplete Packaging (2017)

Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.

FDAJun 28, 2017Nationwide• Valeant Pharmaceuticals North America LLC

CLENZIderm Pore Therapy (Valeant) – Product Discoloration (2017)

Discoloration.

FDAMar 20, 2017Nationwide• Valeant Pharmaceuticals North America LLC

CLENZIderm Acne Treatment System (Valeant) – Product Discoloration (2017)

Discoloration.

FDAMar 20, 2017Nationwide• Valeant Pharmaceuticals North America LLC

Seconal Sodium Capsules (Valeant) – missing anaphylaxis warning (2016)

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

FDAJun 10, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Lodrane D (Valeant) – Mislabeled Carton Packaging (2016)

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

FDAMay 23, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Fenoglide (Valeant) – dissolution failure (2015)

Failed Dissolution Specifications: Failed 24 month dissolution testing.

Class IIModerate

FDASep 4, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Chlordiazepoxide/Clidinium Capsules (Valeant) – Impurity Specs (2015)

Failed Impurities/Degradation Specifications

FDAApr 18, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Librax Capsules (Valeant) – Impurity Specs (2015)

Failed Impurities/Degradation Specifications

FDAApr 18, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Nifedipine Extended-Release Tablets (Valeant) – Dissolution Failure (2015)

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Class IIModerate

FDAApr 17, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Virazole (Valeant) – Non-sterile contamination (2014)

Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

Class IIModerate

FDADec 31, 2014Nationwide• Valeant Pharmaceuticals North America LLC

APLENZIN (Valeant) – Missing Package Insert (2014)

Labeling: Incorrect or Missing Package Insert

FDAJun 5, 2014Nationwide• Valeant Pharmaceuticals North America LLC