notyard
04-14-2009, 02:19 PM
FDA class II recall--more of the zillions of items recalled for multiple cGMP violations by Actavis Totowa:
PRODUCT
a) Phentermine Hydrochloride Capsules, 15 mg, packaged in blister packs of 14 and 28 and bottles of 30 and 60, Schedule IV, Rx only. a) Product number: 4143-0 (28 capsules); b) Product number: 4143-2 (14 capsules); c) Product number: 4143-4 (30 capsules); d) Product number 4143-5 (60 capsules). Recall # D-183-2009;
b) Phentermine Hydrochloride Capsules, 37.5 mg, packaged in blister packs of 28 and bottles of 30, Schedule IV, Rx only. a) Product number: 4816-1 (30 capsules); b) Product number 4816-2 (28 capsules). Recall # D-184-2009;
c) Phentermine Hydrochloride Tablets, 37.5 mg, packaged in blister packs of 7, 14 and 28 and bottles of 30, 45, 60 and 100, Schedule IV, Rx only. a) Product number: 3203-0 (30 tablets); b) Product number: 3203-1 (14 tablets); c) Product number: 3203-2 (7 tablets), d) Product number: 3203-3 (60 tablets); e) Product number: 3203-4 (45 tablets); f) Product number: 3203-8 (28 tablets); g) Product number: 5224-2 (100 tablets). Recall # D-185-2009;
d) Phenazopyridine Tablets, 100 mg, packaged in blister packs of 10, Rx only. Product number: 0199-0 (10 tablets. Recall # D-186-2009;
e) Hyoscyamine Sulfate Tablets 0.125 mg packaged in blister packs of 20, Rx only. Product number: 3763-2 (20 tablets). Recall # D-187-2009;
f) Prenatal Plus w/27 mg Iron Tablets, Multivitamin/multimineral supplement, packaged in bottles of 30, Rx only. Product number: 4552-1 (30 tablets). Recall # D-188-2009;
g) Sodium Fluoride Chewable Tablets, 1.1 mg, equivalent to 0.5 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2870-1 (100 tablets). Recall # D-189-2009;
h) Sodium Fluoride Chewable Tablets, 2.2 mg, equivalent to 1.0 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2871-1 (100 tablets). Recall # D-190-2009;
i) Cyclobenzaprine HCL Tablets, 5 mg, packaged in bottles of 30, Rx only. Product number: 5782-0 (30 tablets). Recall # D-191-2009;
j) Trimethobenzamide HCL Capsules, 300 mg, packaged in blister packs of 6 and 12, Rx only. a) Product number: 5589-0 (12 capsules); b) Product number: 5589-1 (6 capsules). Recall # D-192-2009;
k) Tizanidine HCL Tablets, 2 mg, packaged in bottles of 30, Rx only. Product number: 5443-0 (30 tablets). Recall # D-193-2009;
l) Tizanidine HCL Tablets, 4 mg, packaged in bottles of 15, 30, 60 and 120, Rx only.
a) Product number: 5500-0 (120 tablets); b) Product number: 5500-2 (60 tablets); c) Product number 5500-3 (15 tablets); d) Product number 5500-4 (30 tablets). Recall # D-194-2009
CODE
a) a) Lot numbers: 6353294, 7046061, 7064197, 7064227, 7086179, 7176189, 7218310, 7261156 and 8028255; b) lot numbers: 6362168, 7064198, 7156173, 7186021 and 7299072; c) lot numbers: 6285188, 6326161, 7046009, 7052150, 7142221, 7200019, 7274235, 7306094, 7351190, 7254042, 8077139 and 8127175; d) lot numbers: 6356076, 7046008, 7142222, 7166063, 7176190 and 7200018;
b) a) Lot numbers: 7052149, 7086178, 7141205, 7200016, 7339221, 7347066, 8052097 and 8137081; b) lot numbers: 7150130, 7227122, 7309215, 8023140 and 8081124;
c) a) Lot numbers: 6248181, 6270214, 6297240, 8321028, 6326160, 6347195, 6362172, 7036225, 7036226, 7036227, 7047031, 7050173, 7053032, 7064196, 7071230, 7086175, 7089079, 7107172, 7117045, 7127197, 7135185, 7143113, 7145036, 7145037, 7176181, 7200020, 7200021, 7207018, 7242022, 7242023, 7268184, 7289212, 7292061, 7306092, 7306093, 7313032, 7324225, 7352208, 7360034, 8002001, 8003057, 8025072, 8032115, 8028234, 8044104, 8051106, 8060101, 8067026, 8067027, 8074096, 8081120, 8088070, 8102062, 8102063, 8112202, 8130093, 8135092, 8134131 and 8134152; b) lot numbers: 6297241, 7030207, 7036224, 7036228, 7045139, 7050217, 7086177, 7135186, 7144018, 7288173, 7365192, 7354041, 8081121 and 8133154; c) lot numbers: 7945143, 7050186, 7059197, 7107171, 7130065, 7143115, 7268183, 8023120, 8081122 and 8087021; d) lot numbers: 6270215, 6282199, 6321027, 6333012, 7003117, 7127198, 7141220, 7227121, 7317179, 8095101 and 8107099; e) lot numbers: 6258012, 6284181, 7047032, 7086176, 7120122, 7134221, 7136127, 7176182, 8024089, 8043204, 8052118, 8074105 and 8130095; f) lot numbers: 6270265, 6296189, 6362136, 7071231, 7129142, 7152044, 7220125, 7285100, 8039081 and 8123107; g) lot numbers: 7274226, 7344209, 8009151, 8023119, 8031105, 8084156 and 8130094;
d) Lot number: 7254195;
e) Lot numbers: 6040156, 6303249, 6348264, 7124111 and 7149170;
f) Lot numbers: 6230072, 6335058, 7075075, 7186040, 7241170 and 7250053;
g) Lot numbers: 6018214, 6100189, 6103128, 6128153, 6156190, 6160024, 7138051, 7163136, 7214015, 7234134, 7241180 and 8150026;
h) Lot numbers: 5319231, 6100190 and 6128154;
i) Lot numbers: 7099219, 7135183, 7151061, 7171121, 7183269, 7239200, 7260240, 7310156, 7310157, 8010045, 8102078 and 8189189;
j) a) Lot numbers: 6313276, 7038210, 7130107, 7201041, 7306089, 7316239, 8067051 and 8107154; b) lot numbers: 7123003, 7243036, 7268170, 7306090 and 8050216;
k) Lot numbers: 6304073, 6313206, 6340179, 6348178, 7002214, 7005057, 7067082, 7075030 and 7092179;
l) a) Lot numbers: 6321049, 7024146, 7025068, 7032066, 7250041 and 7271095;
b) lot numbers: 6286118, 7038209, 7064207, 7064208, 7073180, 7085158, 7093155, 7096091, 7115108, 7115109, 7123070, 7130092, 7135192, 7215064, 7242047, 7271066 and 7271094; c) lot numbers: 6313195, 7053065, 7096092 and 7130091; d) lot numbers: 6293054, 6321079, 7033052, 7085185, 7093171, 7096073, 7114144 and 7138034
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allscripts, Libertyville , IL , by letters on July 1, 2008, July 2, 2008, July 11, 2008, July 14, 2008, August 1, and August 4, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON
Multiple cGMP deviations and stability failures found at the manufacturer, Actavis Totowa LLC.
VOLUME OF PRODUCT IN COMMERCE
655,418 capsules, 5,629,312 tablets
DISTRIBUTION
Nationwide
PRODUCT
a) Phentermine Hydrochloride Capsules, 15 mg, packaged in blister packs of 14 and 28 and bottles of 30 and 60, Schedule IV, Rx only. a) Product number: 4143-0 (28 capsules); b) Product number: 4143-2 (14 capsules); c) Product number: 4143-4 (30 capsules); d) Product number 4143-5 (60 capsules). Recall # D-183-2009;
b) Phentermine Hydrochloride Capsules, 37.5 mg, packaged in blister packs of 28 and bottles of 30, Schedule IV, Rx only. a) Product number: 4816-1 (30 capsules); b) Product number 4816-2 (28 capsules). Recall # D-184-2009;
c) Phentermine Hydrochloride Tablets, 37.5 mg, packaged in blister packs of 7, 14 and 28 and bottles of 30, 45, 60 and 100, Schedule IV, Rx only. a) Product number: 3203-0 (30 tablets); b) Product number: 3203-1 (14 tablets); c) Product number: 3203-2 (7 tablets), d) Product number: 3203-3 (60 tablets); e) Product number: 3203-4 (45 tablets); f) Product number: 3203-8 (28 tablets); g) Product number: 5224-2 (100 tablets). Recall # D-185-2009;
d) Phenazopyridine Tablets, 100 mg, packaged in blister packs of 10, Rx only. Product number: 0199-0 (10 tablets. Recall # D-186-2009;
e) Hyoscyamine Sulfate Tablets 0.125 mg packaged in blister packs of 20, Rx only. Product number: 3763-2 (20 tablets). Recall # D-187-2009;
f) Prenatal Plus w/27 mg Iron Tablets, Multivitamin/multimineral supplement, packaged in bottles of 30, Rx only. Product number: 4552-1 (30 tablets). Recall # D-188-2009;
g) Sodium Fluoride Chewable Tablets, 1.1 mg, equivalent to 0.5 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2870-1 (100 tablets). Recall # D-189-2009;
h) Sodium Fluoride Chewable Tablets, 2.2 mg, equivalent to 1.0 mg fluoride ion, packaged in bottles of 100, Rx only. Product number: 2871-1 (100 tablets). Recall # D-190-2009;
i) Cyclobenzaprine HCL Tablets, 5 mg, packaged in bottles of 30, Rx only. Product number: 5782-0 (30 tablets). Recall # D-191-2009;
j) Trimethobenzamide HCL Capsules, 300 mg, packaged in blister packs of 6 and 12, Rx only. a) Product number: 5589-0 (12 capsules); b) Product number: 5589-1 (6 capsules). Recall # D-192-2009;
k) Tizanidine HCL Tablets, 2 mg, packaged in bottles of 30, Rx only. Product number: 5443-0 (30 tablets). Recall # D-193-2009;
l) Tizanidine HCL Tablets, 4 mg, packaged in bottles of 15, 30, 60 and 120, Rx only.
a) Product number: 5500-0 (120 tablets); b) Product number: 5500-2 (60 tablets); c) Product number 5500-3 (15 tablets); d) Product number 5500-4 (30 tablets). Recall # D-194-2009
CODE
a) a) Lot numbers: 6353294, 7046061, 7064197, 7064227, 7086179, 7176189, 7218310, 7261156 and 8028255; b) lot numbers: 6362168, 7064198, 7156173, 7186021 and 7299072; c) lot numbers: 6285188, 6326161, 7046009, 7052150, 7142221, 7200019, 7274235, 7306094, 7351190, 7254042, 8077139 and 8127175; d) lot numbers: 6356076, 7046008, 7142222, 7166063, 7176190 and 7200018;
b) a) Lot numbers: 7052149, 7086178, 7141205, 7200016, 7339221, 7347066, 8052097 and 8137081; b) lot numbers: 7150130, 7227122, 7309215, 8023140 and 8081124;
c) a) Lot numbers: 6248181, 6270214, 6297240, 8321028, 6326160, 6347195, 6362172, 7036225, 7036226, 7036227, 7047031, 7050173, 7053032, 7064196, 7071230, 7086175, 7089079, 7107172, 7117045, 7127197, 7135185, 7143113, 7145036, 7145037, 7176181, 7200020, 7200021, 7207018, 7242022, 7242023, 7268184, 7289212, 7292061, 7306092, 7306093, 7313032, 7324225, 7352208, 7360034, 8002001, 8003057, 8025072, 8032115, 8028234, 8044104, 8051106, 8060101, 8067026, 8067027, 8074096, 8081120, 8088070, 8102062, 8102063, 8112202, 8130093, 8135092, 8134131 and 8134152; b) lot numbers: 6297241, 7030207, 7036224, 7036228, 7045139, 7050217, 7086177, 7135186, 7144018, 7288173, 7365192, 7354041, 8081121 and 8133154; c) lot numbers: 7945143, 7050186, 7059197, 7107171, 7130065, 7143115, 7268183, 8023120, 8081122 and 8087021; d) lot numbers: 6270215, 6282199, 6321027, 6333012, 7003117, 7127198, 7141220, 7227121, 7317179, 8095101 and 8107099; e) lot numbers: 6258012, 6284181, 7047032, 7086176, 7120122, 7134221, 7136127, 7176182, 8024089, 8043204, 8052118, 8074105 and 8130095; f) lot numbers: 6270265, 6296189, 6362136, 7071231, 7129142, 7152044, 7220125, 7285100, 8039081 and 8123107; g) lot numbers: 7274226, 7344209, 8009151, 8023119, 8031105, 8084156 and 8130094;
d) Lot number: 7254195;
e) Lot numbers: 6040156, 6303249, 6348264, 7124111 and 7149170;
f) Lot numbers: 6230072, 6335058, 7075075, 7186040, 7241170 and 7250053;
g) Lot numbers: 6018214, 6100189, 6103128, 6128153, 6156190, 6160024, 7138051, 7163136, 7214015, 7234134, 7241180 and 8150026;
h) Lot numbers: 5319231, 6100190 and 6128154;
i) Lot numbers: 7099219, 7135183, 7151061, 7171121, 7183269, 7239200, 7260240, 7310156, 7310157, 8010045, 8102078 and 8189189;
j) a) Lot numbers: 6313276, 7038210, 7130107, 7201041, 7306089, 7316239, 8067051 and 8107154; b) lot numbers: 7123003, 7243036, 7268170, 7306090 and 8050216;
k) Lot numbers: 6304073, 6313206, 6340179, 6348178, 7002214, 7005057, 7067082, 7075030 and 7092179;
l) a) Lot numbers: 6321049, 7024146, 7025068, 7032066, 7250041 and 7271095;
b) lot numbers: 6286118, 7038209, 7064207, 7064208, 7073180, 7085158, 7093155, 7096091, 7115108, 7115109, 7123070, 7130092, 7135192, 7215064, 7242047, 7271066 and 7271094; c) lot numbers: 6313195, 7053065, 7096092 and 7130091; d) lot numbers: 6293054, 6321079, 7033052, 7085185, 7093171, 7096073, 7114144 and 7138034
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allscripts, Libertyville , IL , by letters on July 1, 2008, July 2, 2008, July 11, 2008, July 14, 2008, August 1, and August 4, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON
Multiple cGMP deviations and stability failures found at the manufacturer, Actavis Totowa LLC.
VOLUME OF PRODUCT IN COMMERCE
655,418 capsules, 5,629,312 tablets
DISTRIBUTION
Nationwide