—#30988

Product

Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.

FDA product code: HMX — Cannula, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lots: #5047293 and #5048892

Why it was recalled

The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.

Root cause (FDA determination)

Other

Action the firm took

The firm contacted their consignees on 12/11/2003 by telephone and letter.

Recalling firm

Firm: Cardinal Health
Address: 6540 Port Rd, Groveport, Ohio 43125-9103

Distribution

Distribution pattern: The product was distributed to customers in OH and PA.

Timeline

Recall initiated: 2003-12-11
Posted by FDA: 2004-01-14
Terminated: 2004-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.