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Terminated

Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

FDA Recall Z-1635-2010 · Posted 2010-05-21

Recalling FirmFerring Pharmaceuticals Inc
Recall StatusTerminated
Product CodeMOZ
Date Initiated2010-04-16
Date Terminated2010-07-27
Product Quantity29,376 cartons with 3 syringes per carton.

Reason for Recall

Out of Specification results for molecular weight or viscosity through the established expiration date.

Firm Action

Ferring Pharmaceuticals issued a "Medical Device Recall" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm. For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.

Root Cause

Process control

Distribution Pattern

Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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