Showing 12 of 64 records
Page 3 of 6Cbi Laboratories, INC.
Options Rx Anti-oxidant Oil-free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), …
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Cbi Laboratories, INC.
Advanced Protection Sunscreen SPF 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5…
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Product Quest Manufacturing LLC
Cicatricure, Scar Cream + Sunscreen SPF 30 (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7…
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Milbar Laboratories, INC.
T Shampoo for Hair and Body, Solution Coal Tar 3% (0.6% Coal Tar), 300 Ml/10.1 FL
Subpotent
Milbar Laboratories, INC.
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 Ml/10.01 FL
Subpotent
Akorn, INC.
Triamcinolone Acetonide Lotion, Usp 0.1%, 60 ML Bottle, Rx Only, Marketed by: Versapharm…
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
A&h Focal INC.
Indian God Lotion Spray Bottle, Labeling Is in Foreign Language
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms,…
Vi-jon, INC.
Equate Beauty Clarifying Face Daily Moisturizer 4 FL
Failed Stability Specifications
Linde Eckstein Gmbh + Co kg
Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl Methoxycinnamide 4%) Body…
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Vintage Pharmaceuticals LLC, Dba Qualitest Pharmaceuticals
Hydrocortisone Lotion, Usp, 2.5%, 2 FL OZ (59 ML) Bottle, Rx Only, Manufactured for: Qualitest…
Superpotent Drug: above specification for the assay.
Valeant Pharmaceuticals North America LLC
Clenziderm M.d
Discoloration.
Cipher Pharmaceuticals US LLC
Inova (Benzoyl Peroxide) 4%, Easy Pad (Tocopherol) 5%, for Topical Use Only, Packaged in a Box…
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
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