Z-1635-2010

Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring...

Name: Z-1635-2010 Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring...
Creator: Ferring Pharmaceuticals Inc
Published: 2010-04-16
License: https://open.fda.gov/license/

Ferring Pharmaceuticals Inc / initiated 2010-04-16 / Terminated / root cause: manufacturing process

FDA source

Ferring Pharmaceuticals Inc began a recall of Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054... on 2010-04-16. The reason FDA records is "Out of Specification results for molecular weight or viscosity through the established expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1635-2010
Status: Terminated
Initiated: 2010-04-16
Posted: 2010-05-21
Terminated: 2010-07-27
Recalling firm: Ferring Pharmaceuticals Inc
Product: 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.
Product code: MOZ Acid, Hyaluronic, Intraarticular
Reason for recall: Out of Specification results for molecular weight or viscosity through the established expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 29,376 cartons with 3 syringes per carton.
Distribution: Nationwide distribution.
Product codes and lots: Lot Numbers: RC0101A, Exp. 5/2010; RC0102A, Exp. 5/2010; RC0107A, Exp 5/2010; RC0114A, Exp 5/2010; RC0118A, Exp 6/2010; RC0122A, Exp 6/2010; RC0123A, Exp 6/2010; RC0127A, Exp 6/2010; and RC0131A, Exp 6/2010.

Product code MOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)