• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

SangCya (Cyclosporine Oral Solution) Dear Distributor Letter Jul 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from SangStat Medical Corporation. Contact the company for a copy of any referenced enclosures.


(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:

  1. Immediately cease distribution of SangCya to your customers
  2. Immediately place all SangCya located at your distribution center in quarantine.
  3. Respond to SangStat within three business days, indicating how much SangCya is located at your distribution center. Provide your reply by filling out the enclosed questionnaire and faxing to SangStat at 510-789-4637, Attention: SangCya Recall. Please provide a response even if your distribution center has no SangCya.
  4. Return all SangCya on hand within ten business days for a full credit. An RGA is not required. Ship SangCya freight collect to: SangStat Medical Corporation, 4580 Mendenhall Road, Memphis, TN 38141, Attention: SangCya Recall.
  5. If SangCya has been transferred or sold to other wholesalers or distributors, please indicate so on the enclosed questionnaire so that SangStat can ensure that the recall notification is sent to those centers.

    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)


 

SangCya Recall
Inventory Questionnaire

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:


SangStat Medical Corporation
6300 Dumbarton Circle
Fremont, CA 94555