Prescription and over-the-counter medications
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
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.
Subpotent Drug: Drug potency was compromised during shipment.
Caraco Pharmaceutical Laboratories
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Failed Tablet Specifications: Broken Tablets Present.
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
Mylan Pharmaceuticals
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Failed Stability Testing: This product is below specification for preservative content.
Failed Tablet/Capsule Specifications: Broken tablets
Teva Pharmaceuticals USA
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Insight Instruments
Marketed without an Approved NDA/ANDA.
Faria Limited LLC
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.