This action is being taken with the knowledge of the United States Food and Drug Administration. This causes concern that the effective dose may not be achieved if patients were to exercise the full 25 C storage option. The apparent differences in potency are attributed to a reagent used during the initial testing.
Potency continues to remain stable when product is refrigerated.
We are requesting your cooperation in the return of the above-mentioned lots as a precautionary measure. Please examine your stock and immediately determine if you have any of the above-mentioned lots on hand and, if so, cease use and return them to the address below. If you have further distributed the product, you must send notification of this withdrawal to your customers. You will be credited for your returned goods and the associated shipping charges. Thank you for your assistance.