7,088 vials Sandoz Estradiol valerate injection: impurities

[notyard]

FDA Class III recall:

PRODUCT
a) Sandoz, Estradiol Valerate Injection, USP, 40 mg per mL, 5 mL Multiple Dose Vial,
Rx only, Sterile, NDC 0781-3031-75, Recall D-268-2008;
b) Sandoz, Estradiol Valerate Injection, USP, 20 mg per mL, 5 mL Multiple Dose Vial,
Rx only, Sterile, NDC 00781-3029-75, Recall # D-269-2008;
c) Sandoz, Estradiol Valerate Injection, USP, 10 mg per mL, 5 mL Multiple Dose Vial,
Rx only, Sterile, NDC 0781-3030-75, Recall # D-270-2008
CODE
a) Lot number 130964;
b) Lot number 138050;
c) Lot number 144500
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on May 16, 2008 and June 6, 2008.
Manufacturer: Sandoz Canada, Inc., Boucherville, Canada. Firm initiated recall is ongoing.
REASON
Drug product exceeded the unknown impurity specification during stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,088/5mL vials
DISTRIBUTION
Nationwide