(SafetyAlerts) - The FDA has released the following information.
PRODUCT
Prozac Capsules Weekly (Fluoxetine Hydrochloride), Delayed Release Capsules, 90 mg fluoxetine, 4 capsules blister pack, Rx Only. Recall # D-342-3.
CODE
6RH73N (1-NOV-2004), 6RH36N (1-OCT-2004), 6RC15P (1-AUG-2004), 6MF17R (1-JUL-2004), 6RA33V (1-AUG-2004), 6MG40N (1-AUG-2004), 5MX93N (1-FEB-2004), 5NC81N (1-OCT-2003), 5MS53N (1-OCT-2003), 5MS52N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter on August 8, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling; Lot number and expiration date are not printed on the external carton labeling.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide
PRODUCT
Prozac Capsules Weekly (Fluoxetine Hydrochloride), Delayed Release Capsules, 90 mg fluoxetine, 4 capsules blister pack, Rx Only. Recall # D-342-3.
CODE
6RH73N (1-NOV-2004), 6RH36N (1-OCT-2004), 6RC15P (1-AUG-2004), 6MF17R (1-JUL-2004), 6RA33V (1-AUG-2004), 6MG40N (1-AUG-2004), 5MX93N (1-FEB-2004), 5NC81N (1-OCT-2003), 5MS53N (1-OCT-2003), 5MS52N (1-SEP-2003).
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter on August 8, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling; Lot number and expiration date are not printed on the external carton labeling.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide
