Prescription and over-the-counter medications
Procter & Gamble
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Samantha Lynn
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Vintage Pharmaceuticals LLC
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Dr. Reddy's Laboratories
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
American Enterprises LLC
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
New England Compounding Center
Lack of Assurance of Sterility
GMP deficiencies
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
New England Compounding Center
GMP Deviations