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View Full Version : Goldline Senna-Gen & Senna-S laxative tablets: undeclared ingredient


notyard
10-20-2009, 04:18 PM
FDA class II recall:

PRODUCT
1) Goldline SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 1000 and 100 count Tablets. NDC 0182-1093-10 (1000 count bottle) and NDC 0182-1093-01(100 count bottle) IVAX SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 100 (10X10) unit dose tablets. NDC 0812-8215-89 (100 count bottle). Recall # D-001-2010;
2) Goldline SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 1000 tablets. NDC 0182-1113-10 (1000 Tablets) and NDC 0182-1113-01 (100 Tablets) IVAX SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 100 Count Unit Dose Tablets. NDC 0182-8642-89 (1000 Tablets). Recall # D-002-2010;
CODE
1) 100 Ct Unit Dose, IVAX Label A019UA, A025UA, C040UA, A019UA, A025UA, C040UA 100 Ct bottles, Goldline Label 89A019U, 89A021U, 89A033T, 89A127U, 89A129U, 89B047T, 89B048T, 89B049T, 89D135U, 89E034U, 89F012U, 89F013U, 89F062U, 89G100U, 89G103T, 89G105T, 89J103T, 89K031S, 89K031T, 89K064S, 89K108S, 89K109S, 89M099S 1000 count bottles, Goldline Label 89A020U, 89A128U, 89C081U, 89D031U, 89D104T, 89E003U, 89F010U, 89F037S, 89F059U, 89F061U, 89G017U, 89G102T, 89G103T, 89H099T, 89J102T, and 89J104T;
2) 100 Ct Unit Dose, IVAX Label 89A156U, 89A156UA, 89B046U, 89B046UA, 89G119T, 89G119TA, 89C019T, 89C019TA--- 100 Ct bottles, Goldline Label 89A115U, 89D071U, 89F102S, 89J019S, 89L019S, 89A156UA, 89D072U, 89F103S, 89J063S, 89L081T, 89B045U, 89D074U, 89F104SM 89J064S, 89M026T, 89B062T, 89D081U, 89F007T, 89J065S, 89M062S, 89B064T, 89D104U, 89G019U, 89J105T, 89M071T, 89M065T, 89D105U, 89G115T, 89J125T, 89M072T, 89D034U, 89D108T, 89G119T, 89K113S, 89D035U, 89D109T, 89H053U, 89L018S--- 1000 CT bottles Goldline Label 89A112U, 89A115U, 89B057T, 89B060T, 89B061T, 89D107T, 89D109T, 89D110T, 89F016U, 89F018U, 89F019U, 89F020U, 89F021U, 89F022U, 89G116T, 89G117T, 89G118T, 89G122T, 89H017U, 89H020U, 89H021U, 89H044T, 89H054U, 89J124T, 89K033S, 89K034S, 89L018S, 89L039U, 89L040U, 89M095T, 89M096T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Weston, FL, by letter on April 16, 2009.
Manufacturer: Time-Cap Laboratories, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Undeclared ingredient; may contain undeclared excipients anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
1,521,771
DISTRIBUTION
Nationwide