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(SangStat Medical Corporation)
July 10, 2000
Wholesale Distribution Center
Attention: Inventory Control Manager
Re: Urgent Class II Recall of SangCya ® (Cyclosporine Oral Solution, USP [Modified])
Dear Inventory Control Manager:
On July 10, 2000 SangStat Medical Corporation initiated a Class II recall of SangCya (Cyclosporine Oral Solution, USP [Modified]). SangCya has been available as a single product form and strength under NDC 62053-539-05, 100 mg/mL, 50 mL bottle. All marketed lots since market introduction are subject to the recall, including lots referenced in the enclosure. SangStat's records indicate that one or more of these lots of SangCya have been shipped to your distribution center. Your assistance with the recall of SangCya is requested and required. This recall is being conducted to the distribution center level only.
A study in healthy volunteers has identified that SangCya is not bioequivalent to Neoral ® Oral Solution when mixed with apple juice as recommended in its labeling. SangStat is taking this Class II recall action with the knowledge of the Food and Drug Administration. Communication from SangStat to medical professionals and pharmacists will take place shortly.
SangStat is requesting your cooperation in the following steps:
At this time in order to allow for the orderly transitioning of patients to other products the recall is limited to the wholesale level and not extended to the pharmacy or the patient. However, patients and pharmacies will be made aware of the recall and may wish to return SangCya. In the event that your distribution center receives returns of SangCya, you may continue to return SangCya to SangStat for a full credit.
Please contact Jeff Ajer, 510-789-4348 at SangStat with any questions you may have about the recall of SangCya.
Sincerely,
Steve Aselage
Senior Vice President, Sales
(SangStat Medical Corporation)
Fax to: 510-789-4637
SangStat Medical Corporation
Attention: SangCya Recall
Wholesale Distribution Center
Date:
Lot Number Units on Hand
2MG69M ________________
1NC30P ________________
1NG00M ________________
1NE00M ________________
2MH05N ________________
2MH06M ________________
2MH06MA ________________
2MH07M ________________
2MH07MA ________________
2MH04N ________________
2MH52M ________________
2MH52MA ________________
2MH53M ________________
2MR63N ________________
2MR64N ________________
2ND22M ________________
2ND22MA ________________
2NE50M ________________
If SangCya has been transferred or sold to other wholesalers or distributors, please provide the name and address below: