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MEDICAL PRODUCT RECALL

Drug Manufacturer Novartis initiates consumer-level recall of isolated lot for Diovan (valsartan) 160 mg high blood pressure

Medco has informed PSEG of a consumer-level recall of Diovan 160 mg tablets from lot F0976 (which were distributed exclusively to Medco) because three Diovan HCT 320/12/5 mg tablets were found in bottles labeled as Diovan 160 mg tablets. According to the Novartis assessment, this is an isolated event and the recall of prescriptions to patients is being conducted as a precaution. 

Below is more information on this recall.

  • Product and strengths: Diovan (valsartan) 160mg tablets
  • Indication: to treat high blood pressure
  • Manufacturer: Novartis
  • Date of recall: March 16, 2011
  • Type of recall: Voluntary, consumer level recall
  • Reason for recall: three Diovan HCT 320/12/5 mg tablets were found in bottles labeled as Diovan 160 mg tablets. Ingesting Diovan HCT 320/12/5 mg tablets when the intended drug is Diovan 160 mg tablets could result in a significant adverse event
  • NDC of recalled product: 0078-0359-17
  • Affected lot numbers: lot F0976 distributed exclusively to Medco
  • Medco patients impacted: approximately 20,000

Return/Replacement information: replacements will be sent to all patients who have received medication from the impacted lot. The impacted lot was dispensed from February 3, 2011 through March 3, 2011. Medco will send a self-addressed, postage paid envelope for patients to return recalled product back to Medco. Medco will return product for to Novartis for analysis.

What to do if you use the MEDCO Pharmacy and are taking Diovan

For members using the Medco Pharmacy, Medco is:

Mailing letters informing patients about the recall with instructions on replacements and what to do with affected product.

  • Mailing replacement product to affected members.
  • Mailing postage paid envelopes so impacted members can return recalled product.
  • Mailing letters to physicians of affected patients informing them of the recall including the list of their patients impacted.
  • Posting web messaging on www.medco.com.
  • Establishing a recall 800 number for handling patient inquiries.
  • Developing/distributing a customer service and pharmacist Q&A to aid in answering incoming inquiries.

If you have questions regarding this information, please contact Benefits Express at 1-800-571-0400.  

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