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Terminated

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 Recall Z-0346-04 · Posted 2004-01-14

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeHMX
Date Initiated2003-12-11
Date Terminated2004-04-08
Product Quantity110 vials

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

The product was distributed to customers in OH and PA.

Official Source

View FDA Recall →

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

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