PharmaFab Agrees to Stop Manufacture and Distribution of Drugs
PharmaFab, Inc., a major manufacturer and distributor of more than 100 different prescription and over-the-counter drugs, has been ordered by the FDA to stop the illegal manufacture and distribution of drugs. The company did not produce the drugs according to the required current good manufacturing practice (CGMP) and may not have obtained required FDA approval.
Many of the drugs produced by the company are cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers are advised to consult with their doctors if using any products by PharmaFab.
Drugs made by PharmaFab include, but are not limited to:
- De-Congestince Sustained Release Capsules;
- GFN 1200/DM 60/PSE 60 Extended Release Tablets;
- Rhinacon A Tablets;
- Sudal 12 Chewable Tablets;
- Histex PD 12 Suspension;
- Atuss HX CIII;
- Ergotrate Tablets;
- Hyoscyamine Sulfate Time-Release Capsules.
Standards established by current good manufacturing practice (CGMP) include investigating manufacturing failures, having an effective quality control unit, and establishing reliable expiration dates for products. Compliance is necessary to make certain that drugs have the required safety, identity, strength, quality, and purity. Because of lack of compliance with CGMP, PhamaFab is required to destroy certain illegal drugs and not distribute any drugs until after obtaining required FDA approval and comply with CGMP.
The FDA news release regarding PharmaLab is available on the FDA website.
Before taking any medication, please consult with your doctor first.