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NuVision Pharmacy Announces Voluntary Recall, Sterility Assurance Concerns

En Español

On April 15, 2013, the NuVision Pharmacy announced a voluntary recall of  all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The cause of the recall is due to issues involving a lack of sterility assurance and quality control processes spotted during an FDA inspection. The U.S. Food and Drug Administration are aware of the recall.

Possible Risk Involved

Patients may face the risk of life threatening infections if the recalled product is compromised. Although there have been no reports of injury or illness caused by the products, NuVision Pharmacy has nonetheless decided to continue with the recall, in the interest of its consumers.

How To Handle The Recall

The offices of licensed medical professionals were supplied with the products and the drug was distributed nationwide. Customers have been informed to return the products back to the NuVision Pharmacy. Health care providers with questions regarding this recall should be directed to NuVision at 800-914-7435 (M-F, 10 AM to 6 PM), or at [email protected]. Any patients with concerns over the recall should contact their healthcare provider.

Reporting Problems

Patients experiencing harmful reactions or issues with the quality of the recalled drugs should be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be made online: www.fda.gov/medwatch/report.htm; through regular mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form; or faxed: 1-800-FDA-0178