FDA Recall
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.
Recall: Z-0346-04
·
Initiated December 11, 2003
Recall
- Recall Number
- Z-0346-04
- Event Number
- 28002
- Firm
- Cardinal Health
- FEI Number
- 3004293943
- Product Code
- HMX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 11, 2003
- Posted
- January 14, 2004
- Terminated
- April 8, 2004
- Address
- 6540 Port Rd, Groveport, OH, 43125-9103
Description
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.
Reason
The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
Action
The firm contacted their consignees on 12/11/2003 by telephone and letter.
Distribution
The product was distributed to customers in OH and PA.
Quantity
110 vials