(SafetyAlerts) - The FDA has released the following information.
PRODUCT
Novocol Octocaine 50 Lidocaine Hydrochloride 2% with Epinephrine 1:50,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP). 50 cartridges/1.8 mL, For Dental Block and Infiltration Only, Rx Only. Also sold under brands as: Henry Schein Lidocaine HCI 2% and Epinephrine 1:50,000 Injection, Super-Dent Lidocaine Hydrochloride 2% and Epinephrine 1:50,000. Recall # D-045-4.
CODE
Lot No/Exp date: 2058 (12/03), 2058A (12/03), 2073 (12/03), 2073A (12/03), 2079 (1/04), 2094 (1/04), 2094A (1/04), 2094B (1/04), 2116A (1/04), 2150 (4/04), and 2150A (04/04). Lot No 2095 was shipped to foreign accounts only.
RECALLING FIRM/MANUFACTURER
Septodont Inc., New Castle, DE, by letter dated October 6, 2003. Firm initiated recall is ongoing.
REASON
Subpotent for Epinephrine ingredient.
VOLUME OF PRODUCT IN COMMERCE
32,748 boxes.
DISTRIBUTION
Nationwide, Armenia, Chile, and Taiwan.
PRODUCT
Novocol Octocaine 50 Lidocaine Hydrochloride 2% with Epinephrine 1:50,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP). 50 cartridges/1.8 mL, For Dental Block and Infiltration Only, Rx Only. Also sold under brands as: Henry Schein Lidocaine HCI 2% and Epinephrine 1:50,000 Injection, Super-Dent Lidocaine Hydrochloride 2% and Epinephrine 1:50,000. Recall # D-045-4.
CODE
Lot No/Exp date: 2058 (12/03), 2058A (12/03), 2073 (12/03), 2073A (12/03), 2079 (1/04), 2094 (1/04), 2094A (1/04), 2094B (1/04), 2116A (1/04), 2150 (4/04), and 2150A (04/04). Lot No 2095 was shipped to foreign accounts only.
RECALLING FIRM/MANUFACTURER
Septodont Inc., New Castle, DE, by letter dated October 6, 2003. Firm initiated recall is ongoing.
REASON
Subpotent for Epinephrine ingredient.
VOLUME OF PRODUCT IN COMMERCE
32,748 boxes.
DISTRIBUTION
Nationwide, Armenia, Chile, and Taiwan.
