Recall of PharmaTech Products Expanded
August 8, 2016 – In mid-July, Burkholderia cepacia (B. cepacia) bacteria were found in samples of Diocto Liquid (docusate sodium) oral solution that were made by PharmaTech and distributed by Rugby® Laboratories. PharmaTech recalled all lots of Rugby-labeled Diocto at that time. Since then PharmaTech extended the recall to include numerous products distributed not only by Rugby, but also by Bayshore Pharmaceuticals, Centurion Labs, Major® Pharmaceuticals, Metron and Virtus Pharmaceuticals. B. cepacia infections usually are not serious, but they can be life-threatening for patients with lung conditions or immune system disorders. Only oral liquid dosage forms of the recalled drugs and supplements are affected by the recall. PharmaTech is a company that manufactures multiple oral liquid medications for distribution by other companies. Many of them are over-the-counter products, such as vitamin drops and laxative syrups.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.