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U.S. Department of Health and Human Services

Class 3 Device Recall Euflexxa (1 sodium hyaluronate)

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 Class 3 Recall
Euflexxa (1 sodium hyaluronate)
see related information
Date Posted May 21, 2010
Recall Status1 Terminated on July 27, 2010
Recall Number Z-1635-2010
Recall Event ID 55407
Premarket Approval
PMA Number
P010029
Product Classification Acid, Hyaluronic, Intraarticular - Product Code MOZ
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.
Code Information 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.
Recalling Firm/
Manufacturer
Ferring Pharmaceuticals Inc
4 Gatehall Dr Fl 3rd
Parsippany, New Jersey 07054-4518
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Paul Stapel
973-796-1636
Manufacturer Reason
for Recall
Out of Specification results for molecular weight or viscosity through the established expiration date.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MOZ and Applicant = FERRING PHARMACEUTICALS, INC.
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