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FDA Recalls(6月17日)

公開日時 2009/07/02 04:00
FDA Recalls  
CLASS II
Various Products Recalled by Advantage Dose LLC
3) Pangestyme EC, Pancrelipase D-R, CAP, Mfg ETH, Rx only, NDC 58177-0031-06, Adv. Dose. Recall # D-664-2009; 7) Verapamil HCl ER, Extended Release, 180 MG TAB, MYL, Rx only, NDC 00378-1180-01, ADV Dose. Recall # D-668-2009; 9) Nalbuphine, 20 MG/ML AMP, Mfg. Rx only, Mfg. HOS, Advantage - Dose. Recall # D-670-2009; 10) Belladonna Alk W/PB, Oral Elixir, Mfg. Rx only, Mfg. QLT, Advantage - Dose. Recall # D-671-2009; 11) Lescol, Fluvastatin Sodium, 20 MG CAP, Mfg NVT, Rx only, NDC 00078-0176-15, Adv Dose. Recall # D-672-2009; 12) Lescol XL, Fluvastatin ER, 80 MG TAB, Mfg NVT, Rx only, NDC 00078-0354-15, Adv Dose. Recall # D-673-2009; 13) Propranolol, Sub: Inderal LA, 60MG CAP, Mfg PAR, Rx only, NDC 49884-0282-01, Adv Dose. Recall # D-674-2009; 15) Stalevo, Carbid/L-Dopa/Entac, 25/100/200MG TAB, Mfg. NVT, Rx only, NDC 00078-0408-05, Adv Dose. Recall # D-676-2009; 16) Vitamin E, Softgel, 400 I Units, Mfg. RUG, NDC 00536-4799-01, Adv Dose. Recall # D-677-2009; 18) Felodipine ER, 2.5MG TAB, Mfg MUT, Rx only, NDC 53489-0368-01, Adv Dose. Recall # D-679-2009; 19) Benzonatate, 100MG SoftGel, Mfg. BAN, Rx only, NDC 50111-0851-01, Adv Dose. Recall # D-680-2009; 20) Sanctura, Trospium Chloride, 20MG TAB, Mfg EPT, Rx only, NDC 15456-0980-04, Adv Dose. Recall # D-681-2009; 22) ZIAGEN, Abacavir Sulfate, 300 MG TAB, MFG GSK, Rx only, Advantage - Dose. Recall # D-683-2009; 24) Amiodarone, 200MG TAB, Mfg TAR, Rx only, NDC 51672-4025-04, Adv Dose. Recall # D-685-2009; 25) Hydralazine HCl, 25MG TAB, Mfg PLV, Rx only, NDC 50111-0327-01, Adv Dose. Recall # D-686-2009; 26) Altoprev, Lovastatin ER, 60MG TAB, Mfg. WAT, Rx only, NDC 59630-0630-30, Adv Dose. Recall # D-687-2009; 27) Fludrocortisone, 0.1MG TAB, Mfg. GLO, Rx only, NDC 00115-7033-01, Adv Dose. Recall # D-688-2009; 28) Ropinirole HCL, 1MG TAB, Mfg. MYL, Rx only, NDC 00378-5501-01, Adv Dose. Recall # D-689-2009; 29) Isosorbide Dinitrate, 10MG TAB, Mfg W-W, Rx only, NDC 00143-1771-01, Adv Dose. Recall # D-690-2009; 30) Singulair, Montelukast, 5MG Chew TAB, Mfg MSD, Rx only, NDC 00006-0275-31, Adv Dose. Recall # D-691-2009; 31) Minocycline HCl, 100MG CAP, Mfg WAT, Rx only, Adv Dose. Recall # D-692-2009; 32) Actonel, Risedronate Sodium, 30MG TAB, Mfg. P&G, Rx only, Adv Dose. Recall # D-693-2009; 33) Derma-Smoothe/FS, Flucinolone, 0.01% Scalp Oil, Mfg HIL, Rx only, Advantage Dose. Recall # D-694-2009; 34) Fluoxetine HCl, 10MG CAP, Mfg UDL, Rx only, Advantage - Dose. Recall # D-695-2009; 36) Risperidone, 1MG TAB, Mfg. PAT, NDC 50458-0592-60, Rx only, Adv Dose. Recall # D-697-2009; 38) Levothroid, Levothyroxine Sodium, 112MCG TAB, Mfg FOR, Rx only, NDC 00456-1330-01, Adv Dose. Recall # D-699-2009; 39) Tricor, Fenofibrate, 48MG TAB, Mfg ABB, Rx only, NDC 00074-6122-90, Adv Dose. Recall # D-700-2009; 40) Midodrine HCl, 2.5MG TAB, Mfg. A-C, NDC 60505-1320-01, Rx only, Adv Dose. Recall # D-701-2009; 41) Risperidone, 1MG TAB, Mfg. TEV, NDC 00093-7240-06, Rx only, Adv Dose. Recall # D-702-2009; 42) Myfortic D-R, Mycophenolic Acid, 360MG TAB, Mfg. NVT, Rx only, NDC 00078-0386-66, Adv Dose. Recall # D-703-2009; 43) Isosorbide, sub: Isordil Titra, 30MG TAB, Mfg. PAR, Rx only, NDC 49884-0009-01, Adv Dose. Recall # D-704-2009; 44) Plaretase, Pancrelipase, NO MG TAB, Mfg. ETH, Rx only, NDC 58177-0416-04, Adv Dose. Recall # D-705-2009; 48) Avalide, Irbesartan/HCTZ, 300/12.5MG TAB, Mfg BRI, Rx only, NDC 00087-2776-31, Adv Dose. Recall # D-709-2009; 50) Synthroid, Levothyroxine, 25MCG TAB, Mfg ABB, Rx only, Adv Dose. Recall # D-711-2009; 52) Lidocaine HCl, Uro-Jet, 2% Jelly, 10MG, Mfg. IMS, Rx only, Advantage Dose. Recall # D-713-2009; 54) Quinapril, 5MG TAB, Mfg. GRN, Rx only, NDC 59762-5019-01, Advantage Dose. Recall # D-715-2009; 57) Detrol, Tolterodine Tartrate, 2MG TAB, Mfg PFZ, Rx only, NDC 00009-4544-02, Adv Dose. Recall # D-718-2009; 58) Terbutaline, sub: Brethine, 2.5MG TAB, Mfg IMP, Rx only, NDC 00115-2611-01, Adv Dose. Recall # D-719-2009; 59) Primidone, sub: Mysoline, 50MG TAB, Mfg LAN, Rx only, NDC 00527-1301-01, Adv Dose. Recall # D-720-2009; 60) Symbyax, Olanzapine/Fluoxetne, 6MG/50MG CAP, Mfg ILI, Rx only, NDC 00002-3233-30, Adv Dose. Recall # D-721-2009; 61) Evista, Raloxifene HCl, 60MG TAB, Mfg LIL, Rx only, NDC 00002-4165-02, Adv Dose. Recall # D-722-2009; 62) Isosorbide, sub: Isordil, 20MG TAB, Mfg QLT, Rx only, NDC 00603-4118-21, Adv Dose. Recall # D-723-2009; 63) Nitroglycerin Extended-Release, 6.5MG CAP, Mfg ETH, Rx only, NDC 58177-0005-03, Adv Dose. Recall # D-724-2009; 64) Cognex, Tacrine HCl, 10MG CAP, Mfg HOR, Rx only, NDC 59630-0190-12, Adv Dose. Recall # D-725-2009; 65) Rythmol SR, Propafenone ER, 325MG CAP, Mfg REL, Rx only, NDC 65726-0262-15, Adv Dose. Recall # D-726-2009; 67) Amitriptyline, 10MG TAB, Mfg QLT, Rx only, NDC 00603-2212-21, Adv Dose. Recall # D-728-2009; 68) Folbee Plus, Folic Acid/Mul Vit TAB (No MG), Mfg. CPC, Rx only, NDC 51991-0082-90, Adv Dose. Recall # D-729-2009; 70) Quinapril HCl, sub: Accupril, 20MG TAB, Mfg A-C, Rx only, NDC 60505-0174-00, Adv Dose. Recall # D-731-2009; 71) Hydroxyzine Pam, sub: Vistaril, 100MG CAP, Mfg WAT, Rx only, NDC 00591-5788-01, Adv Dose. Recall # D-732-2009; 72) Nortriptyline, sub: Pamelor, 50MG CAP, Mfg WAT, Rx only, NDC 00591-5788-01, Adv Dose. Recall # D-733-2009; 73) Acyclovir, 200MG Susp, Mfg APH, Rx only, NDC 00472-0082-16, Adv Dose. Recall # D-734-2009; 74) Actos, Pioglitazone HCl, 15MG TAB, Mfg TPA, Rx only, NDC 64764-0151-04, Adv Dose. Recall # D-735-2009; 75) Triamterene/HCTZ, 37.5 Mg/25MG TAB, Mfg WAT, Rx only, NDC 00591-0424-01, Adv dose. Recall # D-736-2009; 76) Nabumetone, 500MG TAB, Mfg SNZ, Rx only, NDC 00185-0145-01, Adv Dose. Recall # D-737-2009; 78) Paroxetine HCL, sub: Paxil CR, 12.5MG TAB, Mfg, MYL, Rx only, NDC 00378-2003-93, Adv Dose. Recall # D-739-2009; 79) Pangestyme CN-20, Pancrelipase DR, No MG, CAP, Mfg ETH, Rx only, NDC 58177-0030-04, Adv Dose. Recall # D-740-2009; 80) Periogard Oral Rinse, Chlorhexidine Gluconate 0.12% LIQ, 15ML, Mfg C-O, Rx only, NDC 00126-0271-16, Adv Dose. Recall # D-741-2009; 81) Theo-24, Theophylline ER, 300MG CAP, Mfg UCB, Rx only, NDC 50474-0300-01, Adv Dose. Recall # D-742-2009; 84) Pilocarpine HCl, sub: Salagen, 5MG TAB, Mfg LAN, Rx only, NDC 00527-1313-01, Adv Dose. Recall # D-745-2009; 88) Physostigmine, 1MG/ML AMP, 2ML, Mfg TAY, Rx only, NDC 11098-0510-02, ****Advantage Dose not on label***. Recall # D-749-2009; 89) Flurbiprofen Ophth, 0.03% Drop, 2.5ML, Mfg B&L, Rx only, Adv Dose. Recall # D-750-2009; 90) Atenolol/Chlrthl., Aten/Chlorthalidone, 50/25MG TAB, Mfg WAT, Rx only, NDC 00591-5782-01, Adv Dose. Recall # D-751-2009; 91) Sustiva, Efavirenz, 600MG TAB, Mfg BRI, Rx only, Adv Dose. Recall # D-752-2009; 92) Disopyramide, 150MG CAP, Mfg WAT, Rx only, Adv Dose. Recall # D-753-2009; 93) Neomy-Polymx-Grm, Opth Drop, 10ML, Mfg B&L, Rx only, Advantage Dose. Recall # D-754-2009; 96) Kinevac, Sincalide, 5MCG VIAL, Mfg BDI, Rx only, Advantage Dose. Recall # D-757-2009; 99) Guanfacine HCl, 1MG TAB, Mfg WAT, Rx only, NDC 00591-0444-01, Adv Dose. Recall # D-760-2009; 100) Hydrocortisone, 10MG TAB, Mfg QLT, Rx only, NDC 00603-3900-21, Adv Dose. Recall # D-761-2009; 101) Antibiotic HC EAR, NEO/POLY/B/HC Otic, 10ML Solution, Mfg B&L, Rx only, NDC 24208-0631-10, ****Advantage Dose not on label****Recall # D-762-2009; 105) Clarithromycin XL, Extended Release, 500MG TAB, Mfg WAT, Rx only, NDC 62037-0777-60, Adv Dose. Recall # D-766-2009; 106) Ropinirole HCL, 1MG TAB, Mfg TEV, Rx only, NDC 00093-5284-01, Adv Dose. Recall # D-767-2009; 110) Captopril, sub: Capoten, 100MG TAB, Mfg SNZ, Rx only, NDC 00781-1839-01, Adv Dose. Recall # D-771-2009; 112) Metolazone, sub: Zaroxolyn, 10MG TAB, Mfg SZ, Rx only, NDC 00185-5600-01, Adv Dose. Recall # D-773-2009; 113) Lamotrigine, 25MG TAB, Mfg TEV, Rx only, NDC 00093-0039-01, Adv Dose. Recall # D-774-2009; 114) Campral, Acamprosate D-R, 333MG TAB, Mfg FOR, Rx only, NDC 00456-3330-01, Adv Dose. Recall # D-775-2009; 115) Trihexyphenidyl HCI, 2MG TAB, Mfg QLT, Rx only, NDC 00603-6240-21, Adv Dose. Recall # D-776-2009; 116) Betaxolol, 10MG TAB, Mfg KVK, Rx only, NDC 10702-0013-01, Adv Dose. Recall # D-777-2009; 117) Diltiazem, sub: Cardizem, 120MG TAB, Mfg TEV, Rx only, NDC 00093-0321-01, Adv Dose. Recall # D-778-2009; 119) Naproxen Sodium, 550MG TAB, Mfg RED, Rx only, NDC 55111-0108-05, Adv Dose. Recall # D-780-2009; 120) Benzonatate, sub: Tessalon Perles, 100MG CAP, Mfg INW, Rx only, NDC 00258-3654-01, Adv Dose. Recall # D-781-2009; 121) Galantamine HBR ER, sub: Razadyne ER, 8MG CAP, Mfg BAR, Rx only, NDC 00555-1020-01, Adv Dose. Recall # D-782-2009; 124) Fluconazole, 200MG TAB, Mfg IVX, Rx only, Adv Dose. Recall # D-785-2009; 125) Effexor, Venlafaxine, 37.5MG TAB, Mfg WYE, Rx only, Adv Dose. Recall # D-786-2009; 126) Actonel, Risedronate, 5MG TAB, Mfg P&G, Rx only, Adv Dose. Recall # D-787-2009; 130) Medrol, Methylprednisolone, 8MG TAB, Mfg PFZ, Rx only, Adv Dose. Recall # D-791-2009; 133) Coreg, Carvedilol, 3.125MG TAB, Mfg GSK, Rx only, NDC 00007-4139-20, Adv Dose. Recall # D-794-2009; 134) Coreg, Carvedilol, 6.25MG TAB, Mfg SKB, Rx only, NDC 00007-4140-20, Adv Dose. Recall # D-795-2009; 136) Amitiza, Lubiprostone, 25MCG CAP, Mfg TPA, Rx only, NDC 64764-0240-60, Adv Dose. Recall # D-797-2009; 137) Amantadine HCL, sub: Symmetrel, 100MG CAP, Mfg UPS, Rx only, NDC 00832-1015-00, Adv Dose. Recall # D-798-2009; 138) Tegretol-XR, Carbamazepine ER, 400MG TAB, Mfg NVT, Rx only, NDC 00078-0512-05, Adv Dose. Recall # D-799-2009; 139) Triamterene/HCTZ, 37.5/25MG TAB, Mfg A-C, Rx only, NDC 60505-2656-01, Adv Dose. Recall # D-800-2009; 140) Avalide, Irbesartan/HCTZ, 300/12.5MG TAB, Mfg BRI, Rx only, NDC 00087-2776-32, Adv Dose. Recall # D-801-2009; 141) Chlordiazpx,W/ Amitriptyline, 5/12.5MG CAP, Mfg QLT, Rx only, Adv Dose. Recall # D-802-2009; 142) Renal Cap, Vitamin Supplement, CAP, Mfg CYP, Rx only, NDC 60258-0162-01, Adv Dose. Recall # D-803-2009; 144) Fosrenol, Lanthanum Carb Chew, 500MG TAB, Mfg SHI, Rx only, NDC 54092-0252-90, Adv Dose. Recall # D-805-2009; 145) Strattera, Atomoxetine HCl, 18MG CAP, Mfg, LIL, Rx only, NDC 00002-3238-30, Adv Dose. Recall # D-806-2009; 146) Strattera, Atomoxetine HCl, 60MG CAP, Mfg LIL, NDC 00002-3239-30, Adv Dose. Recall # D-807-2009; 147) Strattera, Atomoxetine HCl, 25MG CAP, Mfg LIL, Rx only, NDC 00002-3228-30, Adv Dose. Recall # D-808-2009.
Manufacturer: Advantage Dose LLC, Shreveport, LA.
Recalled by: Manufacturer, by telephone, electronic mail, and letter beginning Nov. 26, 2008. Firm-initiated recall is ongoing.
Distribution: Nationwide; 2,635,663 unit doses for all recalled products, including OTC products not listed.
Reason: Not in conformance with cGMP.
Recall numbers: D-664-2009; D-668-2009; D-670-2009; D-671-2009; D-672-2009; D-673-2009; D-674-2009; D-676-2009; D-677-2009; D-679-2009; D-680-2009; D-681-2009; D-683-2009; D-685-2009; D-686-2009; D-687-2009; D-688-2009; D-689-2009; D-690-2009; D-691-2009; D-693-2009; D-694-2009; D-695-2009; D-697-2009; D-698-2009; D-699-2009; D-700-2009; D-701-2009; D-702-2009; D-703-2009; D-704-2009; D-705-2009; D-708-2009; D-709-2009; D-711-2009; D-713-2009; D-714-2009; D-715-2009; D-718-2009; D-719-2009; D-720-2009; D-721-2009; D-722-2009; D-723-2009; D-724-2009; D-725-2009; D-726-2009; D-728-2009; D-731-2009; D-732-2009; D-733-2009; D-734-2009; D-735-2009; D-736-2009; D-737-2009; D-739-2009; D-740-2009; D-741-2009; D-742-2009; D-745-2009; D-749-2009; D-750-2009; D-751-2009; D-754-2009; D-757-2009; D-760-2009; D-761-2009; D-762-2009; D-766-2009; D-767-2009; D-771-2009; D-773-2009; D-774-2009; D-775-2009; D-776-2009; D-777-2009; D-778-2009; D-780-2009; D-781-2009; D-782-2009; D-785-2009; D-786-2009; D-787-2009; D-791-2009; D-794-2009; D-795-2009; D-797-2009; D-798-2009; D-799-2009; D-800-2009; D-801-2009; D-802-2009; D-803-2009; D-805-2009; D-806-2009; D-807-2009; D-808-2009.
CLASS III
Pravastatin Sodium Tablets
10 mg, 1000-tablet bottles, Rx only, NDC 0591-0013-10.
Manufacturer: Bristol-Myers Squibb Manufacturing Company, Mayaguez, PR.
Recalled by: Bristol-Myers Squibb Company, New Brunswick, NJ, by e-mail and letter on March 31, 2009. Firm-initiated recall is ongoing.
Distribution: AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NV, OH, PA, TN, TX, UT, VA, WA and Hawaii; 1,346 bottles.
Reason: Tablets failed dissolution specification at 36 months test interval.
Recall numbers: D-661-2009.
EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Pink Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation.

(The Pink Sheet 6月29日号より)  FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから

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