(SafetyAlerts) - The FDA has released the following information.
PRODUCT
M.T.E. - 6 Concentrated, Mixture of Six Trace Elements Additive (Each mL providing: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg, Iodide 75 mcg), 10 mL Multiple Dose Vial, Must Be Diluted Before IV Use, Rx only, American Pharmaceutical Partners, Inc., Schaumburg, IL, NDC 63323-036-10. Recall # D-317-3.
CODE
Lot numbers 100669 Expiration Date 8-30-03, 110316 Expiration Date 3-30-04 and 111223 Expiration Date 12-30-04.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated July 29, 2003 and August 5, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (Iodide).
VOLUME OF PRODUCT IN COMMERCE
68,650 vials.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada
PRODUCT
M.T.E. - 6 Concentrated, Mixture of Six Trace Elements Additive (Each mL providing: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg, Iodide 75 mcg), 10 mL Multiple Dose Vial, Must Be Diluted Before IV Use, Rx only, American Pharmaceutical Partners, Inc., Schaumburg, IL, NDC 63323-036-10. Recall # D-317-3.
CODE
Lot numbers 100669 Expiration Date 8-30-03, 110316 Expiration Date 3-30-04 and 111223 Expiration Date 12-30-04.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated July 29, 2003 and August 5, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (Iodide).
VOLUME OF PRODUCT IN COMMERCE
68,650 vials.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada
