Valeant Pharmaceuticals North America recalls
FDA enforcement reports naming Valeant Pharmaceuticals North America LLC as the recalling firm.
- Recall reports
- 24
- Class I (serious)
- 0
- Most recent report
- Feb 20, 2019
- Feb 20, 2019Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceansi…Drug · Valeant Pharmaceuticals North America LLCFailed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Class III
- Feb 20, 2019Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187…Drug · Valeant Pharmaceuticals North America LLCFailed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Class III
- Feb 20, 2019Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187…Drug · Valeant Pharmaceuticals North America LLCFailed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Class III
- Feb 20, 2019Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187…Drug · Valeant Pharmaceuticals North America LLCFailed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Class III
- Feb 20, 2019Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187…Drug · Valeant Pharmaceuticals North America LLCFailed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Class III
- Oct 31, 2018Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed…Drug · Valeant Pharmaceuticals North America LLCCGMP 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 ob…Class II
- Oct 31, 2018Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone)Drug · Valeant Pharmaceuticals North America LLCCGMP 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 ob…Class II
- Oct 31, 2018Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bott…Drug · Valeant Pharmaceuticals North America LLCCGMP 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 ob…Class II
- Aug 15, 2018Diazepam Rectal Gel, 2Drug · Valeant Pharmaceuticals North America LLCLabeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.Class III
- Jul 26, 2017Obagi-C Rx System C-Therapy Night CreamDrug · Valeant Pharmaceuticals North America LLCLabeling: 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…Class III
- CLENZIderm M
- CLENZIderm M
- SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct
- Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-cou…
- Librax (5 mg chlordiazepoxide HCl and 2
- Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2
- Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only
- Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only
- Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administrati…
- APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bott…
- APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE b…
- APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE b…
- Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets
- Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals I…
Page 1 of 3