RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II ___________________________________ PRODUCT 1) Tri Vitamins with Fluoride Chewable Tablets, Vitamin A 2500 IU, Vitamin C 60 mg, Vitamin D 400 IU, Fluoride 1.0 mg, 100 tablets, Rx only, Actavis/Amide NDC 52152-002-02; Qualitest NDC: 0603-6300-21; Major NDC: 0904-7810-60, Recall # D-306-2008; 2) Phenazopyridine Hydrochloride Tablets, USP 100 mg; Packaged in 100 and 1000 count bottles, Also manufactured as Pyridium (Phenazopyridine HCL Tablets, USP; Actavis/Amide NDC; 52152-003-02 (100 count); NDC 52152-003-05 (1000 count). Warner Chilcott NDC: 0430-0180-24, Recall # D-307-2008; 3) Phenazopyridine Hydrochloride Tablets, USP 200 mg;. Packaged in 100 and 1000 count bottles Also manufactured as Pyridium (Phenazopyridine HCL Tablets, USP), Activis/Amide NDC: 52152-004-02 (100 count), 52152-004-05 (1000 count: Warner Chilcott NDC: 0410-0181-24 (100 count only) Recall # D-308-2008; 4) Dexchlorpheniramine Maleate Time Release Tablets, 4 mg, Rx only, 100 Tablets, NDC: 52152-014-02, Recall # D-309-2008; 5) Dexchlorpheniramine Maleate Time Release Tablets, 6 mg, Rx only, 100 Tablets, NDC 52152-015-02, Recall # D-310-2008; 6) Amigesic (Salsalate) Tablets, 500 mg, Rx only, NDC 52152-019-02 -100 count; and NDC 52152-019-04 - 500 count bottles, Recall # D-311-2008; 7) Amigesic (Salsalate) Caplets, 750 mg, Rx only, NDC 52152-020-02 - 100 count bottles; and NDC 52152-020-04 - 500 count bottles, Recall # D-312-2008; 8) Yohimbine HCL Tablets, 5.4 mg, Rx only, NDC 52152-032-02 - 100 count bottles; NDC 52152-032-05 - 1000 count bottles, Recall # D-313-2008; 9) Multi Vita-Bets with 0.5 mg F and Fe Chewable Tablets, Multivitamin, Mineral & Fluoride Supplementation, Rx only, 100 Tablet bottles, Recall # D-314-2008; 10) Multi Vita-Bets with 1.0 mg F and Fe Chewable Tablets, Multivitamin, Mineral & Fluoride Supplementation, Rx only, 100 Tablet bottles; NDC 52152-038-02, Recall # D-315-2008; 11) Vitaplex Tablets Film-coated tablets, 100 and 500 count bottles, Rx only, Amide/Actavis, NDC 52152-076-02 - 100 count bottles; Amide/Actavis NDC 52152- 076-04 - 500 count bottles. Also packaged for: Major, as formula B Tablets, 100 count bottles, NDC 0904-2630-60; IVAX, as B-Plex Tablets, 100 count bottles, NDC 0182- 4062-01; Everett, as Strovite, 100 count bottles, NDC 0642-0200-10, Recall # D-316- 2008; 12) Vitaplex Plus Tablets, Film coated tablets, Rx only, 100 and 500 count bottles, Actavis/Amide NDC 52152-077-02 - 100 count bottles; URL as B-Complex Plus Tablets, NDC 0677-1704-01 - 100 count bottles; Actavis/Amide NDC 52152-077-04 - 500 count bottles, Recall # D-317-2008; 13) Vitacon Forte Capsules, Therapeutic Vitamins-Minerals, 100 and 500 count bottles, Rx only, NDC 52152-078-02 - 100 count bottles; NDC 52152-078-04 - 500 count bottles, Recall # D-318-2008; 14) Choline Magnesium Trisalicylate Tablets, (Salicylate content), 500 mg, 100 count bottles, Rx only, (Present as 293 mg of choline salicylate combined with 362 mg of magnesium salicylate to provide 500 mg. salicylate content), Amide NDC 52152-084- 02; Ivax NDC 0182-1899-01 and Qualitest as Tricosal Tablets, NDC 0603-6215-21; All 100 count bottles, Recall # D-319-2008; 15) Choline Magnesium Trisalicylate Tablets, (Salicylate content) 750 mg, 100 count bottles, 750 mg, Rx only, (Present as 440 mg of choline salicylate combined with 544 mg of magnesium salicylate to provide 750 mg. salicylate content), Actavis/Amide NDC 52152-085-02; IVax NDC 0182-1895-01 and Qualitest as Tricosal Tablets NDC 0603-6216-21, Recall # D-320-2008; 16) Choline Magnesium Trisalicylate Tablets, (Salicylate content) 1000 mg, 100 count bottle, Rx only, (Present as 587 mg of choline salicylate combined with 725 mg of magnesium salicylate to provide 1000 mg salicylate content); Amide NDC 52152-086-02, Qualitest NDC 0603-6217-21; 100 count bottles, Recall # D-321-2008; 17) Methenamine Mandelate Tablets. USP 0.5 g, film coated, Rx only, Actavis/Amide NDC 52152-111-02 - 100 count bottles: Actavis/Amide NDC 52152-111-05 ? 1000 count bottles; URL NDC 067701681-01 - 100 count bottles; Warner Chilcott NDC 0430-0166-24 - 100 count bottles, Recall # D-322-2008; 18) Methenamine Mandelate Tablets. USP, 1 gram, 100 and 1000 count bottles, film coated, Rx only, Actaive/Amide NDC 52152-112-02 - 100 count bottles; Actavis/Amide NDC 52152-112-05 - 1000 count bottles; URL NDC 067701682-01 ? 100 count bottles; Warner Chilcott as Mandelamine (Methenamine Mandelate Tablets, USP), NDC 0430-0167-24 - 100 count bottles, Recall # D-323-2008; 19) Bellamine-S Tablets, (Phenobarbital, USP 40mg, Ergotamine Tartrate, USP 0.6mg and Levorotatory alkaloids of belladona 0.2mg), 100 tablets, Rx only, Amide NDC 52152-115-02; Major NDC 0904-2548-60, Recall # D-324-2008; 20) Meclizine HCL Chewable Tablets, 25 mg, Antiemetic, Prevents motion sickness, 100 and 100 tablets bottles, Amide NDC 05152-117-02 - 100 count bottles; Amide NDC 52152-117-05 - 1000 count bottles; Goldline NDC 0182-0571-01 ? 100 count bottles;, Recall # D-325-2008; 21) Sodium Fluoride Tablets, 0.5 mg F, Rx only, Half Strength from 1.1 mg Sodium Fluoride, 1000 count bottles, Actavis NDC 52152-128-05, Recall # D-326-2008; 22) Sodium Fluoride Tablets, USP 1.0 mg F, 1000 count bottles, Full Strength, From 2.2 mg. Sodium Fluoride, Actavis NDC 52152-128-05; URL NDC 067701678-10, Recall # D-327-2008; 23) Amitex PSE Tablets (Guaifenesin and Pseudoephedrine Hydrochloride Tablets 600 mg/120 mg), 100 and 500 count bottles, Rx only, NDC 52152-130-02 -100 count bottles; NDC 52152-130-04 - 500 count bottles, Recall # D-328-2008; 24) Amibid DM Tablets (Guaifenesin and Dextromethorphan Hydrobromide 600 mg/ 30 mg), 100 and 250 count bottles, Rx only, Amide NDC 52152-139-02 - 100 count bottles; Amide NDC 52152-139-03 - 250 count bottles; Ivax NDC 0182-1042-01 ? 100 count bottles, Recall # D-329-2008; 25) Hyoscyamine Sulfate Tablets 0.125 mg; Rx only, 100 tablets, Amide/Actavis NDC 52152-143-02 - 100 count bottles; Major NDC 0904-2496-60, Recall # D-330-2008; 26) Hyoscyamine Sulfate Tablets SL 0.125 mg, 100 tablets bottles, Rx only, sublingual/oral/chewable, Actavis/Amide NDC 52152-155-02; Major NDC 0904- 5120-60, Recall # D-331-2008; 27) Hyoscyamine Sulfate Tablets SR 0.375 mg, Extended Release Tablets, 100 count bottles, Rx only, Actavis/Amide NDC 52152-156-02, Recall # D-332-2008; 28) Phenazopyridine Hydrochloride Tablets 95 mg, Bulk labeled for Actavis - Totowa (Amide) for Johnson & Johnson, Recall # D-333-2008; 29) Oxycodone Hydrochloride Tablets, USP 5 mg, Rx only, 100 count bottle, NDC 52152-165-02, Recall # D-334-2008; 30) Oxycodone Hydrochloride Capsules, (oxycodone hydrochloride immediate ? release), 5 mg,100 capsules, Rx only, NDC 52152-187-02, Recall # D-335-2008; 31) Prenatal Rx Tablets, Multivitamin and Multimineral Supplement with Betacarotene, 1 mg Folic Acid and 54 mg Iron, 200 and 500 count bottles, film coated tablets, NDC 52152-171-20 - 200 count bottles; NDC 52152-171-04 - 500 count bottles, Recall # D-336-2008;. 32) Codeine Phosphate and Guaifenesin Tablets 10 mg/300 mg, 100 Tablets bottles, Rx only, NDC 52152-172-02, Recall # D-337-2008; 33) Prenatal Plus w/27 mg, Iron Tablets, Multivitamin/Multimineral Supplement, Rx only, 100 & 500 Tablets, For use before, during and after pregnancy, Amide/Actavis NDC 52152-178-02 - 100 count bottles; Amide/Actavis NDC 52152-178-04 - 500 count bottles; URL NDC 06077-1689-01 - 100 count bottles; Qualitest, NDC 0603-5361-21 - 100 count bottles, D-338-2008; 34) Pyridium Plus, Each Tablet contains phenazopyridine hydrochloride (Pyridium) 150 mg, hyoscyamine hydrobromide 0.3 mg and butabarbital 15 mg, Rx only, 30 tablets, NDC 0430-0182-15, Recall # D-339-2008; 35) NataFort Prenatal Multivitamin Tablet with Iron, for Use before, during and after pregnancy, Patient Starter kit (5 Tablets in Unit-dose Package) NDC 0430-0226-97; and 90 tablets blister cards (18 unit dose card of 5 tablets each and 9 unit dose cards of 10 tablets each), NDC 0430-0226-40, Recall # D-340-2008; 36) Meperidine HCL and Promethazine HCL Capsules, 100 Capsules bottle, Rx only, NDC 52152-190-02, Recall # D-341-2008; 37) NataChew Chewable Prenatal Multivitamin Tablet with Iron, 90 Tablets, Rx only, for Use before, During and After Pregnancy, NDC 0430-0227-23, Recall # D-342- 2008; 38) Guaifenesin and Dextromethorphan HBr ER Tablets, 1200 mg/60 mg, Rx only, 100 tablets bottle, NDC 52152-246-02, Recall # D-343-2008; 39) Prenatal Formula 3 Prenatal Vitamins, USP, 100 and 500 Tablets bottle, Rx only, NDC 52152-248-02, Recall # D-344-2008; 40) New Ami-Tex LA Tablets (Phenylephrine Hydrochloride and Guaifenesin 30 mg/600 mg), Rx only, 100 Tablets bottle, NDC 52152-253-02, Recall # D-345-2008; 41) Multifol Tablets Vitamin, Iron, Calcium, Rx only 10 x 10 Unit dose pack, 100 tablets; NDC 51991-126-11, Recall # D-346-2008 CODE 1) Lot codes: 60617A1, Exp 07/08; 70479A1, Exp. 06/09; Lot code 60617A1, Exp -7/08; 70479A2, Exp. 06/09; Lot codes 60617A1, Exp 07/08, 070479A1, Exp 06/09; 2) Lot codes: 060976B1, Exp. 11/08; 70539B1, Exp. 07/09; 80069B1, Exp 01/10; 3) All lots within expiry; 4) Lot code 60471A1, Exp. 5/09; 5) Lot codes: 51035A1, Exp 12/08; 5599A!, Exp. 07/08; 5599A2, Exp. 07/08; 6) Lot 60452A2, Exp 5/08; 60965A2, Exp. 11/08; Lot 60452A1, Exp 5/08; 60965A1, Exp 11/08; 7) Lot 5509A2, Exp 6/08; 60457A2, Exp May 08, 60673A2, Exp. 7/08; 60969A2, Exp. 11/08; 70191A2, Exp. 3/09; Lot 5509A1, Exp 6/08; 60457A1, Exp. 5/08; 60673A1, Exp. 7/08; 60969A1, Exp 11/08; 70191A1, Exp/ 3/09; 8) Lot 5681A2, Exp. 8/08; 5681A3, Exp. Aug 08; Lot 5681A1, Exp 8/08; 9) Lot 60538A1, Exp 6/08; 60720A1, Exp. 8/08; 60879A1, Exp 10/08; 61001A1, Exp. 11/08; 61139A1, Exp 12/08; 70190A1, Exp 3/09; 70190A2, Exp. 3/09; 70379A1, Exp. 5/09; 70526A1, Exp. 6/08; 70742A1, Exp 9/09; 70921A1, Exp. 11/09; 71044A1, Exp 1/10; 80206A1, Exp. 3/10; 10) Lot code: 60510A1, Exp. 6/08; 60913A1, Exp. 10/08; 70185A1, Exp 53/09; 70602A1, Exp 7/09; 70922A1, Exp 11/09; 80208A1, Exp 3/10; 11) thru 37), All lots within expiry; 16) Lot code 60881A1, Exp 10/08; 32) Lot numbers 60265A1, Exp. 5/08 and 70040A1, Exp 1/09; 33) All lots within expiry; 34) Lot 60688A1, Exp. 8/08; 38) Lot 60469A1, Exp. May 08; 39) Lot 60920A1, Exp. 10/08; 40) Lot code 60651A1, Exp 8/08; 41) All lots within expiry RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on June 6, 2008. Firm initiated recall is ongoing. REASON cGMP Deviation VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION Nationwide ___________________________________ PRODUCT Longs brand Fruit Flavor Polacrilex Nicotine Gum, 4 mg (nicotine) 40 pieces, stop smoking aid, NDC 12333-0097-0, Recall # D-352-2008 CODE Lots 7LE0794, 7LE0966, 7LV0510, 7ME0761, 8LE0737, 8BE0247, 8BE0911, 8CE0237, 8CE0719 and 8CV0473; EXP 06/2009 RECALLING FIRM/MANUFACTURER L. Perrigo Co., Allegan, MI, by visit on May 19/20-2008. Firm initiated recall is complete. REASON Misbranded; side panel directions incorrectly state "if you smoke less than 25 cigarettes a day; use Nicotine Polacrilex Gum, 4mg" panel should correctly state "if you smoke less than 25 cigarettes a day; use Nicotine Polacrilex Gum, 2mg". VOLUME OF PRODUCT IN COMMERCE 5,320 cartons DISTRIBUTION CA ___________________________________ PRODUCT a) Mandelamine Hafgrams (Methenamine Mandelate Tablets), 0.5 gram, film coated, Rx only, 100 Tablet bottles; NDC 0430-0166-24, Recall # D-353-2008; b) Mandelamine (Methenamine Mandelate Tablets), 1.0 gram, film coated, Rx only, 100 Tablets; NDC 0430-167-24, Recall # D-354-2008; c) Pyridium Tablets (phenazopyridine HCl Tablets, USP), 100 mg, Rx only, 100 tablets, NDC 0430-180-24, Recall # D-355-2008; d) Pyridium Tablets (phenazopyridine HCl Tablets, USP), 200 mg, Rx only, 100 tablets, NDC 0430-0181-24, Recall # D-356-2008; e) Pyridium Plus Tablets (phenazopyridine HCl) Each tablet contains phenzopyridine hydrochloride (Pyridium) 150 mg, hyoscyamine hydrobromide 0.3 mg, butabarbital 15 mg, 30 Tablets, Rx only, NDC 0430-181-15, Recall # D-357-2008; f) NataFort Prenatal Multivitamin Tablet with Iron, Rx only, For use before, during and after pregnancy, 90 Tablets (18 unit dose cards of 5 tablets each), or 9 unit dosed cards of 10 tablets). Also sample pack of 5 tablets in a Unit dose package. NDC 0430-0226-40; NDC 0430-227-97 (Sample 5 pack), Recall # D-358-2008; g) NataChew Chewable Prenatal Multivitamin Tablet with Iron, For use before, during and after pregnancy, Rx only, 90 Tablets; NDC 0430-0227-23, Recall # D-359-2008 CODE a) Lot codes: 5719A1, Exp 8/31/08; 60727A1, Exp. 8/31/09, 70743A1, Exp. 9/30/10; b) Lot codes: 5720A1, Exp. 8/31/08; 60728A1, Exp. 8/31/09; 70140A1, Exp. 02/28/10; 70482A1, Exp. 6/30/10; 70662A1, Exp. 9/30/10; c) Lot codes: 80069B1, Exp. 1/31/10; 60976B1, Exp. 11/30/08; 70539B1, Exp. 7/31/09; d) Lot codes: 60832B1, Exp. 9/30/08; 70659B1, Exp. 09/30/09; e) Lot code 60688A1, Exp. 8/31/08; f) Lot code 60996A2, Exp. 11/30/08; 60996A4, Exp. 11/30/08; 60997A1, Exp. 11/30/08; 60997A2, Exp 11/30/08; 70368A1, Exp. 4/30/09; 70368A4, Exp. 4/30/09; 70631A1, Exp. 8/31/09; Lot codes: 60996A1, Exp. 11/30/08; 70368A2, Exp. 4/30/09; 70368A3, Exp. 4/30/09; g) Lot Codes: 60726A1, Exp. 8/31/08; 70041A1, Exp. 2/28/09; 70358A1, Exp. 4/30/09; 70902A1, Exp. 10/31/09 RECALLING FIRM/MANUFACTURER Recalling Firm: Warner Chilcott Inc., Rockaway, NJ, by letters on June 23, 2008. Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing. REASON cGMP Deviations; Lack of stability indicating test methods. VOLUME OF PRODUCT IN COMMERCE 189,233 (bottles and blister packs) DISTRIBUTION Nationwide ___________________________________ PRODUCT Lisinopril Tablets, USP, 10 mg, 1000 Tablets bottle, Rx only; NDC 0185-0101-10, Recall # D-360-2008 CODE Lot # MK071070 RECALLING FIRM/MANUFACTURER Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on/about June 23, 2008 and July 16, 2008. Manufacturer: Sandoz, Inc., Wilson, NC. Firm initiated recall is ongoing. REASON Presence of Foreign Substance; embedded metal was discovered in a tablet. VOLUME OF PRODUCT IN COMMERCE 1,922 bottles/1000 tablets DISTRIBUTION MO ___________________________________ PRODUCT a) B-Plex Tablets, Multi-vitamin tablets, 100 tablets bottle, Rx only, NDC 0182-4062-01, Recall # D-361-2008; b) Choline Magnesium Trisalicyate, 750 mg, 100 tablets bottle, Rx only, Recall # D-362-2008; c) Choline Magnesium Trisalicyate, 500 mg, 100 tablets bottle, Rx only, Recall # D-363-2008 CODE a) Lot # 60687A2, Exp. 08/2008 Lot # 60904A3, Exp. 10/2008 Lot # 61045A2, Exp. 11/2008 Lot # 70184A3, Exp. 02/2009; b) Lot # 60951A1 Exp. 11/2008; c) Lot # 5437A1 Exp. 06/2008 and 70062A1, Exp. 01/2009 RECALLING FIRM/MANUFACTURER Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on June 13, 2008. Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing. REASON cGMP Deviations; Lack of stability indicating methods by manufacturer. VOLUME OF PRODUCT IN COMMERCE 7,075 bottles DISTRIBUTION AL, FL,GA, IL, KY, LA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, VA and WA ___________________________________ PRODUCT Flecainide Acetate Tablets, 150 mg, 100 count bottles, Rx only, Recall # D-365-2008 CODE Unit: 070669 RECALLING FIRM/MANUFACTURER Recalling Firm: Graceway Pharmaceuticals LLC, Bristol, TN, by letter on June 26, 2008. Manufacturer: 3M Drug Delivery Systems, Northridge, CA. Firm initiated recall is ongoing. REASON Defective container; missing cap liners. VOLUME OF PRODUCT IN COMMERCE 12,563 units DISTRIBUTION WV RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III ___________________________________ PRODUCT Midodrine Hydrochloride Tablets, 2.5 mg, 100 tablets, Rx only; Catalog number: 00185-0090-01, Recall # D-364-2008 CODE Lot #: MK017696 RECALLING FIRM/MANUFACTURER Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on/about June 19, 2008. Manufacturer: Sandoz, Inc., Wilson, NC. Firm initiated recall is ongoing. REASON Subpotent; 6 month stability VOLUME OF PRODUCT IN COMMERCE 5,271 bottles (100 count per bottle) DISTRIBUTION Nationwide Source: FDA Zynchros Pharmacy Services