NRAC Issue #1619 ADDENDUM February 27, 2007 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Levothyroxine Sodium Tablets USP, 25 mcg (0.025 mg), 100 and 1000 tablet bottles, Rx only RECALL NUMBER # D-449-2007 PRODUCT b) Levothyroxine Sodium Tablets, USP, 50 mcg (0.050mg), 100 and 1000 tablet bottles, Rx only RECALL NUMBER # D-450-2007 PRODUCT c) Levothyroxine Sodium Tablets, USP, 75 mcg (0.075mg), 100 and 1000 tablet bottles, Rx only RECALL NUMBER # D-451-2007 PRODUCT d) Levothyroxine Sodium Tablets, USP, 88 mcg (0.088mg), 100 tablet bottles, Rx only RECALL NUMBER # D-452-2007 PRODUCT e) Levothyroxine Sodium Tablets, USP, 100 mcg (0.1mg), 100 and 1000 tablet bottles, Rx only RECALL NUMBER # D-453-2007 PRODUCT f) Levothyroxine Sodium Tablets, USP, 112 mcg (0.112mg), 100 tablet bottles, Rx only RECALL NUMBER # D-454-2007 PRODUCT g) Levothyroxine Sodium Tablets, USP, 125 mcg (0.125mg), 100 tablet bottles, Rx only RECALL NUMBER # D-455-2007 PRODUCT h) Levothyroxine Sodium Tablets, USP, 137 mcg (0.137mg), 100 tablet bottles, Rx only RECALL NUMBER # D-456-2007 PRODUCT i) Levothyroxine Sodium Tablets, USP, 150 mcg (0.150mg), 100 and 1000 tablet bottles, Rx only RECALL NUMBER # D-457-2007 PRODUCT j) Levothyroxine Sodium Tablets, USP, 175 mcg (0.175mg), 100 tablet bottles, Rx only RECALL NUMBER # D-458-2007 PRODUCT k) Levothyroxine Sodium Tablets, USP, 200 mcg (0.200mg), 100 tablet bottles, Rx only RECALL NUMBER # D-459-2007 PRODUCT l) Levothyroxine Sodium Tablets, USP, 300 mcg (0.300mg), 100 tablet bottles, Rx only RECALL NUMBER # D-460-2007 CODE a) C05T2671A 05T2670 Exp Feb. 07, C06T0311A2 06T0020 Exp Jul 07, C06T0311A3 06T0030 Exp Jul 07, C06T0321A3 06T0090 Exp Jul 07, C06T0341A2 06T2630 Exp Aug 07, C06T1051A6 06T6370 Exp Sep 07, C06T0881A1 06T4820 Exp Sep 07, C06T0341A1 06T2620 Exp Aug 07, C06T0341A4 06T2650 Exp Aug 07, C06T0341A5 06T2660 Exp Aug 07, C06T0341A6 06T2670 Exp Aug 07, C06T0361A1 06T2720 Exp Aug 07, C06T0361A2 06T2730 Exp Aug 07, C06T0361A3 06T2740 Exp Aug 07, C06T035IA4 06T2680 Aug 07, C06T0351A2 06T2700 Exp Aug 07, C06T0351A1 06T2690 Exp Aug 07, C06T0871A1 06T4270 Exp Sept 07, C06T0871A2 06T4280 Exp Sep07, C06T0871A5 06T4800 Exp Sep 07, C06T0871A6 06T481O Exp Sep 07, C06Tl041A1 06T6280 Exp Sep 07, C06Tl041A2 06T6300 Exp Sep 07, C06Tl041A3 06T6310 Exp Sep 07, C06T1061A3 06T6400 Exp Sep 07, C06T1051A1 06T6320 Exp Sep 07, C06Tl051A2 06T6330 Exp Sep 07, C06T1051A3 06T6340 Exp Sep 07, C06T0881A2 06T6230 Exp Sep 07, C06T0881A4 06T6250 Exp Sep 07, C06T0881A5 06T6260 Exp Sep 07, C06T0881A6 06T6270 Exp Sep 07, C06T1071A4 06T6450 Exp Oct 07, C06Tl071A6 06T6470 Exp Oct 07, C06Tl081A3 06T6500 Exp Oct 07, C06T0351A3 06T271O Exp Aug 07, C06T0871A3 06T4290 Exp Sep 07, C06T0871A4 06T4300 Exp Sep 07, C06T0881A3 06T6240 Exp Sep 07, C04T1641A 04T12200 Exp Dec 06, C04T1641A 04T12210 Exp Dec 06, C04T1661A 04T12300 Exp Dec 06 b) C06T0211A1 05T2140 Exp Jul 07, C06T0221A2 06T2030 Exp Jul 07, C06T0231A1 06T2040 Exp Jul 07, 06T4831A 06T4830 Exp Sep 07, C06Tl111A1 06T651O Exp Oct 07, C06T0471A1 06T2770 Exp Aug 07, 06T2811A 06T2810 Exp Aug 07, C06T0461A2 06T2760 Exp Aug 07, 06T4351A 06T4350 Exp Sep 07, C06T0481A1 06T2790 Exp Aug 07, C06T0211A2 06T2150 Exp Jul 07, C06T0241A2 06T2180 Exp Jul 07, C06T0241A1 06T2170 Exp Jul 07, C06T0231A2 06T2160 Exp Jul 07, C06T0121A1 06T2210 Exp Jul 07, C06T0121A2 06T2220 Exp Jul 07, C06T0131A1 06T219O Exp Jul 07, 06T2231A 06T2230 Exp Jul 07, C06T0461A1 06T2750 Aug 07, C06T0471A2 06T2780 Exp Aug 07, C06T0481A2 06T2800 Exp Aug 07, C06T0491A1 06T2820 Exp Aug 07, 06T4311A 06T431O Exp Sep 07, C06T0791A1 06T4320 Exp Sep 07, C06T0791A2 06T4340 Exp Sep 07, 05T3441A Exp Apr 07, C05T0071A4 Exp May 07, 05T9061A Exp Jul 07 c) C04T2511A 04T16040 Exp Feb 07, C05T1011A1 05T11320 Exp Feb 07, C05T1011A2 05T11340 Exp Feb 07, C05T1011A3 05T11350 Exp Feb 07, C05T1011A4 05T11360 Exp Feb 07, C05T1011A5 05T11370 Exp Feb 07, C05T1031A4 05T11470 Exp Feb 07, C05T1031A4 05T11480 Exp Feb 07, C05T1041A3 05T11520 Exp Feb 07, C05T1051A1 05T11560 Exp Feb 07, C05T0571A5 05T10870 Exp Dec 06, C05T0571A1 05T9080 Exp Dec 06, 05T7491A 05T7491 Exp May 07, C05T1021A2 05T11390 Exp Feb 07, C05T1021A4 05T11410 Exp Feb 07, C05T1381A2 05T13890 Exp Mar 07, C05T1381A5 05T13920 Exp Mar 07, C05T1391A1 05T13940 Exp Mar 07, C05T1391A4 05T13970 Exp Mar 07, C05T11381A6 05T13930 Exp Mar 07, C05T1381A1 05T11710 Exp Mar 07, C05T1021A3 05T11400 Exp Mar 07, C05T1041A1 05T11500 Exp Feb 07, C05T1041A2 05T11510 Exp Mar 07, C05T1041A4 05T11530 Exp Mar 07, C05T1041A5 05T11540 Exp Mar 07, C05T1041A6 05T11550 Exp Mar 07, C05T1051A2 05T11570 Exp Mar 07, C05T10571A2 05T9090 Exp Mar 07, C05T10571A3 05T9760 Exp Dec 06, C05T0571A4 05T10860 Exp Dec 06, 05T5801A 05T5800 Exp May 07, C05T0231A2 05T6940 Exp 5/07, 05T5661A Exp 4/07, 05T7491A Exp 5/07 d) C05T0841A1 05T7080 Exp May 07 e) C04T2291A Exp Jan 07 f) C04T2251A Exp. Feb 07 g) C05T0431A Exp Feb 07 h) C05T2261A2, C05T2261A3 i) C05T1411A3 05T14130 Exp Mar 07, C05T0941A Exp Apr 07 j) 05T3211A 05T3210 Exp Mar 07, C05T0681A1 Exp May 07 k) C05T0131A1 05T7320 Exp Mar 07, C05T0801A1 05T11200 Exp Jul 07 l) 05T9391A Exp Jul 07, 04T11911A Exp Nov 06 MANUFACTURER Mova Pharmaceutical Corp, Caguas, PR. RECALLED BY ALARA Pharmaceutical Corp, Caguas, PR QUANTITY Unknown DISTRIBUTION Nationwide and PR REASON Subpotent --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19" diameter lighthead; Models IN19, IN19EL, IN19LH and IN19S RECALL NUMBER # Z-0524-2007 PRODUCT b) Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19" diameter lightheads, Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT RECALL NUMBER # Z-0525-2007 PRODUCT c) Skytron Infinity Series surgical light, 4 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF54, IF54EL, IF54LH and IF54S RECALL NUMBER # Z-0526-2007 PRODUCT d) Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF5454 and IF5454EL RECALL NUMBER # Z-0527-2007 PRODUCT e) Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF545454 and IF545454EL RECALL NUMBER # Z-0528-2007 PRODUCT f) Skytron Infinity Series surgical light, 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL) RECALL NUMBER # Z-0529-2007 PRODUCT g) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL RECALL NUMBER # Z-0530-2007 PRODUCT h) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22" lighthead and 8 bulbs in 1 - 30" diameter lighthead. Made in Japan; Model IF3022B. (note only the 22' lighthead is affected.) RECALL NUMBER # Z-0531-2007 PRODUCT i) Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF222222-B, IF222222EL and IN222222EL RECALL NUMBER # Z-0532-2007 PRODUCT j) Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IN3022EL and IF3022EL. (note only the 22' lighthead is affected) RECALL NUMBER # Z-0533-2007 PRODUCT k) Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in each of 2 - 22" diameter lightheads, Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22' lightheads are affected) RECALL NUMBER # Z-0534-2007 CODE a) Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx) b) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx) c) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series:95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx) d) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx) e) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx) f) Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx) g) Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx) h) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB) i) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx) j) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers containing IN and 22 all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx) k) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers containing IN and 22, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx) MANUFACTURER Dai-Ichi Shomei Co., Ltd. Tokyo, Japan RECALLED BY Skytron, Div. The KMW Group, Inc, Grand Rapids, MI QUANTITY Approximately 5,000 units DISTRIBUTION Nationwide and Canada REASON If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. ---------------------------------------------------------------------------